Dietary supplements and formulations

ABSTRACT

Provided are dietary supplements, formulations, kits and methods for administration to an individual with type II diabetes or at risk of developing type II diabetes. Provided herein are formulations, kits and methods useful for treating, preventing, supporting, controlling, restoring, and/or maintaining blood sugar levels in individuals with type II diabetes or at risk of developing the same. Also provided are formulations, kits and methods useful for reducing and/or eliminating requirement of ex-vivo insulin administration in an individual diagnosed with type II diabetes.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.62/116,315, filed Feb. 13, 2015, which is incorporated by referenceherein in its entirety.

BACKGROUND

Diabetes mellitus (DM), commonly referred to as diabetes, is a group ofconditions characterized by high blood sugar levels presented in apatient potentially over a prolonged duration of time. Type II diabetesis a form of diabetes that is generally associated with insulinresistance, a condition in which cells fail to respond to insulinproperly. As the disease progresses, a lack of insulin may also develop.Type II diabetes was previously referred to as “non-insulin-dependentdiabetes mellitus” (NIDDM) or “adult-onset diabetes.”

Disclosed herein are dietary supplements, formulations and methodsuseful for treating, preventing, supporting, controlling, restoring,and/or maintaining blood sugar levels in individuals suffering frompre-diabetic conditions and/or diabetes. The formulations of dietarysupplements and methods of use thereof disclosed herein are also usefulfor treating, preventing, supporting, controlling, restoring, and/ormaintaining blood sugar levels in an individual or a patient or forsupport or treatment of other physiological conditions generallyassociated with type II diabetes.

SUMMARY

An object of the present disclosure is to provide dietary supplements,formulations, kits and methods for administration to an individual withtype II diabetes, an individual who is at risk of developing type IIdiabetes, or to a healthy individual that desires to avoid developingdiabetes. Provided herein are formulations, kits and methods useful fortreating, preventing, supporting, controlling, restoring, or maintainingblood sugar levels in individuals with type II diabetes or at risk ofdeveloping the same. Also provided are formulations, kits and methodsuseful for reducing and/or eliminating requirement of ex-vivo insulinadministration in an individual diagnosed with type II diabetes.

In one aspect, provided herein is a formulation comprising:

-   -   a) group A components consisting essentially of one or more        protein;    -   b) at least one group B component that comprises dandelion        extract, milk thistle extract, phospholipids, ginger, taurine,        turmeric extract, vitamin C, methionine or combinations thereof;    -   c) at least one group C component that comprises magnesium,        trimethylglycine, glutathione, N-acetyl-cysteine, Cordyceps        sinensis extract, glutamine, alpha lipoic acid, glycine or        combinations thereof; and    -   d) an excipient.

Also provided herein is a formulation comprising: group A componentsconsisting essentially of protein selected from the group consisting ofpea protein isolate, sacha inchi protein, hemp protein, rice protein,artichoke protein, chia seed protein, beef protein or combinationsthereof; at least one group B component that comprises dandelionextract, milk thistle extract, phospholipids, ginger, taurine, turmericextract, vitamin C, methionine or combinations thereof; at least onegroup C component that comprises magnesium, trimethylglycine,glutathione, N-acetyl-cysteine, glutamine, alpha lipoic acid, glycine orcombinations thereof; at least one group D component that compriseshesperidin, beet root, enzyme blend, sarsparilla root, bromelain,betaine, methylsulfonylmethane (MSM), choline bitartarate, primrose,inulin, watercress leaf, Panax ginseng root extract, selenium, lecithin,or S-anenosylmethionine (SAM-e), thiamine, vitamin B5, niacin, vitaminE, riboflavin, vitamin B6, folate, vitamin B12, biotin, zinc, copper,molybdenum, carotene, calcium, vitamin D, sodium phosphate, vitamin A,calcium, phosphorus, chromium, triglyceride, quercetin, rutin,Marshmallow extract, Jerusalem artichoke tuber, fiber or combinationsthereof; and an excipient. In some embodiments, the enzyme blendcomprises a lactase, a cellulase, a protease, a lipase, a dismutase, acatalase, or a combination thereof.

Provided herein are formulations useful for treatment and/orstabilization of individuals suffering from type II diabetes or at riskof developing type II diabetes. In some embodiments, provided is aformulation comprising: group A components consisting essentially ofprotein selected from pea protein isolate, sacha inchi protein, hempprotein, rice protein, artichoke protein, chia seed protein, beefprotein or combinations thereof; at least one group B component thatcomprises dandelion extract, milk thistle extract, phospholipids,ginger, taurine, turmeric extract, vitamin C, methionine or combinationsthereof; at least one group C component that comprises magnesium,trimethylglycine, glutathione, N-acetyl-cysteine, Cordyceps sinensisextract, glutamine, alpha lipoic acid, glycine or combinations thereof;and an excipient. In some embodiments, the formulation further comprisespea protein isolate and sacha inchi protein. In some embodiments, theformulation further comprises a protein derived from a source which isnot pea protein isolate. In some embodiments, the formulation furthercomprises a protein derived from a source which is not sacha inchiprotein.

Further provided is a formulation comprising: group A componentsconsisting essentially of maca, Cornus officinalis fruit extract orcombinations thereof; at least one group B component that comprisesberberine, bitter melon extract, Gymnema sylvestre leaf extract, banaba,carnitine or combinations thereof; at least one group C component thatcomprises vitamin C, Panax ginseng root extract, Aswagandha rootextract, holy basil leaf extract, Rhodiola rosea extract,Eleutherococcus senticosus extract, vitamin B5, cactus stem extract,phosphatidylserine, vitamin D or combinations thereof; and an excipient.In some embodiments, the formulation further comprises a fish oilformulation. The fish oil formulation may comprise omega-3 at a range ofabout 15% to about 100%.

Also provided is a formulation comprising: group A components consistingessentially of maca, Cornus officinalis fruit extract or combinationsthereof; at least one group B component that comprises berberine, bittermelon extract, Gymnema sylvestre leaf extract, banaba, or carnitine; atleast one group C component that comprises vitamin C, Panax ginseng rootextract, Aswagandha root extract, holy basil leaf extract, Rhodiolarosea extract, Eleutherococcus senticosus extract, vitamin B5, cactusstem extract, phosphatidylserine, vitamin D or combinations thereof; atleast one group D component that comprises Cordyceps sinesis extract,Gingko biloba leaf extract, suma root, Garcinia cambogia extract,Rehmannia glutinosa extract, Poria cocos root extract, cinnamon extract,Fenugreek, Guggul, citrimax extract, salacia oblonga extract, vitamin E,thiamin, riboflavin, niacin, vitamin B6, folate, vitamin B12, biotin,magnesium, zinc, selenium, manganese, chromium, vanadium, zinc, biotin,alpha lipoic acid, N-acetyl-cysteine, 4-aminobenzoic acid (PABA),choline bitartrate, glutamine, glutathione, protein, fiber, inositol orcombinations thereof; and an excipient.

Still further provided is a formulation comprising: group A componentsconsisting essentially of cactus stem extract; at least one group Bcomponent that comprises berberine, bitter melon extract, Gymnemasylvestre leaf extract, banaba, carnitine or combinations thereof; atleast one group C component that comprises Garcinia cambogia extract,Rehmannia glutinosa extract, Poria cocos root extract, cinnamon extract,Fenugreek, Guggul, Vitamin D or combinations thereof; and an excipient.

Additionally provided is a formulation comprising: group A componentcomprising cactus stem extract; at least one of group B component thatcomprises berberine, bitter melon extract, Gymnema sylvestre leafextract, banaba, carnitine or combinations thereof; at least one group Ccomponent that comprises Garcinia cambogia extract, Rehmannia glutinosaextract, Poria cocos root extract, cinnamon extract, Fenugreek, orGuggul; at least one group D component that comprises vitamin D, vitaminE, thiamin, riboflavin, niacin, vitamin B6, folate, vitamin B12, biotin,vitamin B5, magnesium, zinc, selenium, manganese, chromium, vanadium,alpha lipoic acid, N-acetyl-cysteine, 4-aminobenzoic acid (PABA),choline bitartarate, citrimax extract, taurine, coenzyme Q10, calcium,vitamin K2, vitamin C, protein, fiber, inositol or combinations thereof;and an excipient.

In some embodiments is a formulation described herein, wherein dandelionextract is dandelion root extract. In some embodiments is a formulationdescribed herein, wherein the phospholipids comprise about 40%phosphatidylcholine. In some embodiments is a formulation describedherein, wherein the turmeric extract comprises about 95% curcumin. Insome embodiments is a formulation described herein, wherein milk thistleextract is milk thistle seed extract comprises about 80% silymarin. Insome embodiments is a formulation described herein, optionally furthercomprising a gotu kola extract, which is optionally a gotu kola leafextract. In some embodiments is a formulation described herein, whereinvitamin C comprises L-ascorbic acid, calcium ascorbate, or a combinationthereof. In some embodiments is a formulation described herein, whereinmagnesium is magnesium citrate. In some embodiments is a formulationdescribed herein, wherein glutathione comprises L-glutathione, S-acetylL-glutathione, or a combination thereof. In some embodiments is aformulation described herein, wherein N-acetyl-cysteine is N-AcetylL-cysteine. In some embodiments is a formulation described herein,wherein Cordyceps sinensis extract comprises about 7% cordycepic acid.In some embodiments is a formulation described herein, wherein glutamineis L-glutamine. In some embodiments is a formulation described herein,wherein alpha lipoic acid is alpha R-lipoic acid. In some embodiments isa formulation described herein, wherein glycine is L-glycine. In someembodiments is a formulation described herein, further comprising atleast one group D component that comprises hesperidin, beet root, enzymeblend, sarsaparilla root, bromelain, betaine, methylsulfonylmethane(MSM), choline bitartarate, luo han guo, stevia extract rebaudioside,primrose, inulin, watercress leaf, Panax ginseng root extract, selenium,or S-anenosylmethionine (SAM-e). In some embodiments is a formulationdescribed herein, wherein luo han guo comprises about 40% mogrosides. Insome embodiments is a formulation described herein, wherein the steviaextract rebaudioside is stevia extract 97% rebaudioside. In someembodiments is a formulation described herein, wherein the primrose isevening primrose oil powder. In some embodiments is a formulationdescribed herein, wherein hesperidin is hesperidin complex. In someembodiments is a formulation described herein, wherein beet root is beetroot powder. In some embodiments is a formulation described herein,wherein the enzyme blend comprises a lactase, a cellulase, a protease, alipase, a dismutase, a catalase, or a combination thereof. In someembodiments is a formulation described herein, wherein betaine isbetaine hydrochloride. In some embodiments is a formulation describedherein, wherein choline is choline bitartarate. In some embodiments is aformulation described herein, wherein the watercress leaf is watercressleaf powder. In some embodiments is a formulation described herein,wherein selenium is L-selenomethionine. In some embodiments is aformulation described herein, further comprising at least one group Ecomponent that comprises thiamine, vitamin B5, niacin, vitamin E,vitamin B6, folate, vitamin B12, biotin, zinc, copper, molybdenum,carotene, calcium, vitamin D, sodium phosphate, triglyceride, quercetin,rutin, Marshmallow extract, or Jerusalem artichoke tuber.

In some embodiments is a formulation described herein, wherein thiamineis optionally benfotiamine. In some embodiments is a formulationdescribed herein, wherein vitamin B5 comprises at least one ofpantothenic acid, pantethine, d-calcium pantothenate, or a combinationthereof. In some embodiments is a formulation described herein, whereinniacin comprises at least one of niacinamide, nicotinic acid, or acombination thereof. In some embodiments is a formulation describedherein, wherein vitamin E is d-alpha tocopherol succinate. In someembodiments is a formulation described herein, optionally furthercomprising riboflavin, wherein said riboflavin is optionallyriboflavin-5′-phosphate. In some embodiments is a formulation describedherein, wherein vitamin B6 comprises at least one ofpyridoxal-5-phosphate, pyridoxine HCl, or a combination thereof. In someembodiments is a formulation described herein, wherein folate isL-5-methyltetrahydrofolate.

In some embodiments is a formulation described herein, wherein vitaminB12 is methylcobalamin. In some embodiments is a formulation describedherein, wherein zinc is zinc glycinate. In some embodiments is aformulation described herein, wherein copper is copper gluconate. Insome embodiments is a formulation described herein, wherein molybdenumis molybdenum amino acid chelate. In some embodiments is a formulationdescribed herein, wherein carotene is beta carotene. In some embodimentsis a formulation described herein, wherein calcium is calcium ascorbate.In some embodiments is a formulation described herein, wherein vitamin Dis vitamin D3. In some embodiments is a formulation described herein,wherein sodium phosphate is disodium phosphate. In some embodiments is aformulation described herein, wherein the triglyceride is a triglyceridecomprising about 6-12 carbon fatty acid esters.

In some embodiments is a formulation described herein, wherein quercetinis quercetin dihydrate. In some embodiments is a formulation describedherein, wherein Marshmallow extract is Marshmallow root extract. In someembodiments is a formulation described herein, wherein the concentrationof pea protein isolate in the formulation is from about 5% to about 70%by weight. In some embodiments is a formulation described herein,wherein the concentration of sacha inchi protein in the formulation isfrom about 0.5% to about 10% by weight. In some embodiments is aformulation described herein, wherein the concentration of dandelionextract in the formulation is from about 5% to about 40% by weight. Insome embodiments is a formulation described herein, wherein theconcentration of milk thistle extract in the formulation is from about3% to about 15% by weight. In some embodiments is a formulationdescribed herein, wherein the concentration of phospholipids in theformulation is from about 1% to about 12% by weight. In some embodimentsis a formulation described herein, wherein the concentration of gingerin the formulation is from about 1% to about 10% by weight. In someembodiments is a formulation described herein, wherein the concentrationof taurine in the formulation is from about 0.5% to about 8% by weight.

In some embodiments is a formulation described herein, wherein theconcentration of turmeric extract in the formulation is from about 0.5%to about 8% by weight. In some embodiments is a formulation describedherein, wherein the optionally comprising gotu kola extract in aconcentration up to about 8% by weight. In some embodiments is aformulation described herein, wherein the concentration of vitamin C inthe formulation is from about 1% to about 8% by weight. In someembodiments is a formulation described herein, wherein the concentrationof methionine in the formulation is from about 1% to about 11% byweight. In some embodiments is a formulation described herein, whereinthe concentration of magnesium in the formulation is from about 10% toabout 55% by weight. In some embodiments is a formulation describedherein, wherein the concentration of trimethylglycine in the formulationis from about 1% to about 40% by weight. In some embodiments is aformulation described herein, wherein the concentration of glutathionein the formulation is from about 0.5% to about 35% by weight. In someembodiments is a formulation described herein, wherein the concentrationof N-acetyl-cysteine in the formulation is from about 0.5% to about 30%by weight. In some embodiments is a formulation described herein,wherein the concentration of Cordyceps sinensis extract in theformulation is from about 0.5% to about 6% by weight. In someembodiments is a formulation described herein, wherein the concentrationof glutamine in the formulation is from about 0.5% to about 6% byweight. In some embodiments is a formulation described herein, whereinthe concentration of alpha lipoic acid in the formulation is from about0.5% to about 6% by weight. In some embodiments is a formulationdescribed herein, wherein the concentration of glycine in theformulation is from about 0.5% to about 6% by weight.

In some embodiments is a formulation described herein, wherein theexcipient comprises gelatin, cellulose, medium-chain triglyceride (MCT)oil, silicon dioxide, stearic acid, xanthan gum, potassium sorbate,turmeric powder, primrose oil, lemon oil, or combinations thereof. Insome embodiments is a formulation described herein, wherein theformulation is in a powder form, a semi-solid form, a liquid form, anemulsion form, or a combination thereof.

In some embodiments is a formulation described herein, furthercomprising at least one component that comprises hesperidin, beet root,enzyme blend, sarsaparilla root, bromelain, betaine,methylsulfonylmethane (MSM), choline bitartarate, luo han guo, steviaextract rebaudioside, primrose, inulin, watercress leaf, Panax ginsengroot extract, selenium, or S-anenosylmethionine (SAM-e). In someembodiments is a formulation described herein, further comprising atleast one component that comprises thiamine, vitamin B5, niacin, vitaminE, riboflavin, vitamin B6, folate, vitamin B12, biotin, zinc, copper,molybdenum, carotene, calcium, vitamin D, sodium phosphate,triglyceride, quercetin, rutin, Marshmallow extract, or Jerusalemartichoke tuber. In some embodiments is a formulation described herein,wherein the phospholipids comprise about 40% phosphatidylcholine. Insome embodiments is a formulation described herein, wherein the turmericextract comprises about 95% curcumin. In some embodiments is aformulation described herein, wherein milk thistle extract is milkthistle seed extract comprising about 80% silymarin.

In some embodiments is a formulation described herein, furthercomprising gotu kola extract, wherein optionally said gotu kola extractis gotu kola leaf extract. In some embodiments is a formulationdescribed herein, wherein vitamin C comprises L-ascorbic acid, calciumascorbate, or a combination thereof. In some embodiments is aformulation described herein, wherein glutathione comprisesL-glutathione, S-acetyl L-glutathione, or a combination thereof. In someembodiments is a formulation described herein, wherein Cordycepssinensis extract comprises about 7% cordycepic acid. In some embodimentsis a formulation described herein, wherein luo han guo comprises about40% mogrosides.

In some embodiments is a formulation described herein, wherein thestevia extract rebaudioside is stevia extract 97% rebaudioside. In someembodiments is a formulation described herein, wherein the concentrationof pea protein isolate in the formulation is from about 5% to about 70%by weight. In some embodiments is a formulation described herein,wherein the concentration of sacha inchi protein in the formulation isfrom about 0.5% to about 10% by weight.

In an embodiment is a formulation described herein, wherein berberine isberberine hydrochloride. In some embodiments is a formulation describedherein, wherein carnitine is carnitine tartrate. In some embodiments isa formulation described herein, wherein carnitine is L-carnitineL-tartrate. In some embodiments is a formulation described herein,wherein the Cordyceps sinesis extract is a Cordyceps sinesis myceliumextract. In some embodiments is a formulation described herein, whereinvitamin C is L-ascorbic acid. In some embodiments is a formulationdescribed herein, wherein vitamin B5 comprises at least one ofpantothenic acid, pantethine, d-calcium pantothenate, or a combinationthereof. In some embodiments is a formulation described herein, whereinthe phosphatidylserine is a phospholipid complex supplement. In anembodiment is a formulation described herein, wherein vitamin D is apowder. In some embodiments is a formulation described herein, furthercomprising at least one component that comprises Cordyceps sinesisextract, Gingko biloba leaf extract, suma root, Garcinia cambogiaextract, Rehmannia glutinosa extract, Poria cocos root extract, cinnamonextract, Fenugreek, or Guggul.

In some embodiments is a formulation described herein, wherein Rehmanniaglutinosa extract is Rehmania glutinosa rhizome extract. In someembodiments is a formulation described herein, wherein the Rehmaniaglutinosa rhizome extract is a Rehmania glutinosa rhizome 5:1 extract.

In some embodiments is a formulation described herein, furthercomprising a fish oil formulation. In some embodiments is a formulationdescribed herein, wherein the fish oil formulation comprises omega-3 ata range of about 15% to about 100%. In some embodiments is a formulationdescribed herein, wherein the fish oil formulation compriseseicosapentaenoic acid (EPA) at a range of about 5% to about 100%. Insome embodiments the fish oil formulation comprises docosahexaenoic acid(DHA) at a range of about 10% to about 100%. In some embodiments is aformulation described herein, wherein the fish oil formulation is in apowder form. In some embodiments is a formulation described herein,wherein the fish oil formulation is in a liquid form. In someembodiments is a formulation described herein, wherein the fish oilformulation is in an emulsion form. In some embodiments is a formulationdescribed herein, wherein the fish oil formulation further comprises oneor more of citric acid, luo han guo, sodium citrate, calcium glycinateamino acid complex, magnesium glycinate, zinc glycinate chelate, zincL-monomethionine, pyridoxal-5-phosphate drum, niacin, molybdenum aminoacid chelate, taurine, lecithin, glycerine, and vitamin E.

In some embodiments is a formulation described herein, furthercomprising at least one component that comprises one or more of vitaminE, thiamin, riboflavin, niacin, vitamin B6, folate, vitamin B12, biotin,magnesium, zinc, selenium, manganese, chromium, vanadium, alpha lipoicacid, N-acetyl-cysteine, 4-aminobenzoic acid (PABA), choline bitartrate,or inositol. In some embodiments is a formulation described herein,wherein the concentration of berberine hydrochloride in the formulationis from about 6% to about 28% by weight. In some embodiments is aformulation described herein, wherein the concentration of bitter melonextract in the formulation is from about 0.2% to about 18% by weight. Insome embodiments is a formulation described herein, wherein theconcentration of Gymnema sylvestre leaf extract in the formulation isfrom about 8% to about 18% by weight. In some embodiments is aformulation described herein, wherein the concentration of banaba in theformulation is from about 0.2% to about 18% by weight. In someembodiments is a formulation described herein, wherein the concentrationof cactus stem extract in the formulation is from about 1% to about 8%by weight. In some embodiments is a formulation described herein,wherein the concentration of L-carnitine L-tartrate in the formulationis from about 1% to about 5% by weight. In some embodiments is aformulation described herein, wherein the concentration of Garciniacambogia extract in the formulation is from about 0.1% to about 1% byweight. In some embodiments is a formulation described herein, whereinthe concentration of Rehmannia glutinosa extract in the formulation isfrom about 0.1% to about 3% by weight. In some embodiments is aformulation described herein, wherein the concentration of Poria cocosroot extract in the formulation is from about 0.1% to about 1% byweight. In some embodiments is a formulation described herein, whereinthe concentration of cinnamon extract in the formulation is from about0.1% to about 1% by weight. In some embodiments is a formulationdescribed herein, wherein the concentration of Fenugreek extract in theformulation is from about 0.1% to about 1% by weight.

In some embodiments is a formulation described herein, wherein theconcentration of Guggul extract in the formulation is from about 0.1% toabout 1% by weight. In some embodiments is a formulation describedherein, optionally comprising broad bean extract which is optionally ina concentration from about 0.05% to about 0.25% by weight. In someembodiments is a formulation described herein, wherein the concentrationof Cordyceps sinesis extract in the formulation is from about 0.5% toabout 3% by weight. In some embodiments is a formulation describedherein, wherein the concentration of maca in the formulation is fromabout 0.5% to about 3% by weight. In some embodiments is a formulationdescribed herein, wherein the concentration of Gingko biloba leafextract in the formulation is from about 0.5% to about 3% by weight. Insome embodiments is a formulation described herein, wherein theconcentration of suma root extract in the formulation is from about 0.5%to about 3% by weight. In some embodiments is a formulation describedherein, wherein the concentration of Cornus officinalis fruit extract inthe formulation is from about 0.5% to about 3% by weight.

In some embodiments is a formulation described herein, wherein theconcentration of vitamin C in the formulation is from about 2% to about9% by weight. In some embodiments is a formulation described herein,wherein the concentration of Panax ginseng root extract in theformulation is from about 5% to about 21% by weight. In some embodimentsis a formulation described herein, wherein the concentration ofAswagandha root extract in the formulation is from about 4% to about 16%by weight. In some embodiments is a formulation described herein,wherein the concentration of holy basil leaf extract in the formulationis from about 3% to about 13% by weight. In some embodiments is aformulation described herein, wherein the concentration of Rhodiolarosea extract in the formulation is from about 2% to about 10% byweight. In some embodiments is a formulation described herein, whereinthe concentration of Eleutherococcus senticosus extract in theformulation is from about 1% to about 7% by weight.

In some embodiments is a formulation described herein, wherein theconcentration of vitamin B5 in the formulation is from about 1% to about7% by weight. In some embodiments is a formulation described herein,wherein the concentration of phosphatidylserine is from about 20% toabout 90% by weight. In some embodiments is a formulation describedherein, wherein the excipient comprises gelatin, cellulose, medium-chaintriglyceride (MCT) oil, silicon dioxide, stearic acid, or combinationsthereof.

In some embodiments is a formulation described herein, optionallycomprising broad bean. In some embodiments is a formulation describedherein, wherein berberine is berberine hydrochloride. In someembodiments is a formulation described herein, wherein carnitine iscarnitine tartrate. In some embodiments is a formulation describedherein, wherein carnitine is L-carnitine L-tartrate. In some embodimentsis a formulation described herein, wherein Rehmannia glutinosa extractis Rehmania glutinosa rhizome extract. In some embodiments is aformulation described herein, wherein the Rehmania glutinosa rhizomeextract is a Rehmania glutinosa rhizome 5:1 extract. In some embodimentsis a formulation described herein, wherein vitamin D is a powder. Insome embodiments is a formulation described herein, further comprisingat least one component that comprises vitamin E, thiamin, riboflavin,niacin, vitamin B6, folate, vitamin B12, biotin, vitamin B5, magnesium,zinc, selenium, manganese, chromium, vanadium, alpha lipoic acid,N-acetyl-cysteine, 4-aminobenzoic acid (PABA), choline bitartarate, orinositol. In some embodiments is a formulation described herein, whereinvitamin E is d-alpha tocopherol succinate. In some embodiments is aformulation described herein, wherein thiamin is at least one ofbenfotiamine and thiamine HCl. In some embodiments is a formulationdescribed herein, wherein riboflavin is roboflavin-5′-phosphate. In someembodiments is a formulation described herein, wherein niacin comprisesat least one of niacinamide, nicotinic acid, or a combination thereof.In some embodiments is a formulation described herein, wherein vitaminB6 is at least one of pyridoxal-5-phospate and pyridoxine HCl. In someembodiments is a formulation described herein, wherein folate isL-5-metyltetrahydrofolate.

In some embodiments is a formulation described herein, wherein vitaminB12 is cyanococbalamin. In some embodiments is a formulation describedherein, wherein vitamin B5 comprises at least one of pantothenic acid,d-calcium pantothenate, pantethine, or a combination thereof. In someembodiments is a formulation described herein, wherein magnesium ismagnesium citrate.

In some embodiments is a formulation described herein, wherein zinc iszinc glycinate. In some embodiments is a formulation described herein,wherein selenium is L-selenomethionine. In some embodiments is aformulation described herein, wherein manganese is manganese gluconate.In some embodiments is a formulation described herein, wherein chromiumis chromium niacin complex. In some embodiments is a formulationdescribed herein, wherein vanadium is vanadium sulfate. In someembodiments is a formulation described herein, wherein alpha lipoic acidis alpha R-lipoic acid. In some embodiments is a formulation describedherein, wherein N-acetyl-cysteine is N-Acetyl L-cysteine. In someembodiments is a formulation described herein, wherein the concentrationof berberine hydrochloride in the formulation is from about 6% to about28% by weight. In some embodiments is a formulation described herein,wherein the concentration of bitter melon extract in the formulation isfrom about 0.2% to about 18% by weight. In some embodiments is aformulation described herein, wherein the concentration of Gymnemasylvestre leaf extract in the formulation is from about 8% to about 18%by weight. In some embodiments is a formulation described herein,wherein the concentration of banaba in the formulation is from about0.2% to about 18% by weight. In some embodiments is a formulationdescribed herein, wherein the concentration of cactus stem extract inthe formulation is from about 3% to about 8% by weight. In someembodiments is a formulation described herein, wherein the concentrationof L-carnitine L-tartrate in the formulation is from about 2% to about5% by weight.

In some embodiments is a formulation described herein, wherein theconcentration of Garcinia cambogia extract in the formulation is fromabout 0.2% to about 0.6% by weight. In some embodiments is a formulationdescribed herein, wherein the concentration of Rehmannia glutinosaextract in the formulation is from about 0.2% to about 0.6% by weight.

In some embodiments is a formulation described herein, wherein theconcentration of Poria cocos root extract in the formulation is fromabout 0.2% to about 0.6% by weight. In some embodiments is a formulationdescribed herein, wherein the concentration of cinnamon extract in theformulation is from about 0.2% to about 0.6% by weight. In someembodiments is a formulation described herein, wherein the concentrationof Fenugreek in the formulation is from about 0.2% to about 0.6% byweight. In some embodiments is a formulation described herein, whereinthe concentration of Guggul in the formulation is from about 0.2% toabout 0.6% by weight.

In some embodiments is a formulation described herein, optionallyfurther comprising broad bean powder in a concentration from about 0.2%to about 0.6% by weight. In some embodiments is a formulation describedherein, wherein the excipient comprises gelatin, cellulose, medium-chaintriglyceride (MCT) oil, silicon dioxide, stearic acid, xanthan gum,potassium sorbate, turmeric powder, primrose oil, lemon oil, orcombinations thereof.

Provided herein are methods comprising administration of at least oneformulation described herein, for the treatment of diabetes in subject.In some embodiments, provided are methods for the treatment ofpre-diabetic symptoms in a subject. In certain embodiments, provided aremethods for the regulation of blood sugar in a subject. Certain methodsdescribed herein may comprise administration of a formulation describedherein for the regulation of insulin levels in a subject.

Further provided are methods for the treatment of type II diabetes in asubject comprising: administering to the subject a first formulationdescribed herein for at least about 10 days; administering to thesubject a second formulation described herein for at least about 30days; and optionally administering to the subject a third formulationdescribed herein. In some embodiments, a formulation described herein isadministered with an additional agent. The additional agent may compriseinsulin, metformin, sulfonylureas, meglitinides, thiazolidinediones,DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, or acombination thereof.

In some embodiments, provided is a method of supporting glucose level ina subject's blood comprising administering to the subject one or moreformulations described herein. In some embodiments is a method ofsupporting glucose level in a subject's blood comprising administeringto the subject a formulation described herein, and optionallyadministering to the subject a second or additional formulation or agentdescribed herein.

Provided are kits for use in the methods described herein. In someembodiments, provided are kits comprising at least one formulationdescribed herein; and instructions for use thereof. In certainembodiments, provided is a kit that further comprises at least one dietplan or meal plan. In some embodiments, the kit further comprises atleast one recipe.

In some embodiments is a kit useful for treating, preventing,supporting, controlling, restoring, or maintaining blood sugar levels inan individual comprising: at least one formulation described herein;instructions for use of the at least one formulation; and optionally atleast one diet plan.

A diet plan described herein may further comprise recipes. In someembodiments, the diet plan further comprises recipes for at least one ofbreakfast, lunch, snacks, and dinner. In some embodiments, at least onediet plan is tailored to complement said at least one formulation. Insome embodiments, the diet plan is tailored based on the level of atleast one indicator in the individual. In certain cases, the at leastone indicator is body mass index (BMI), liver fat level or hemoglobinA1C count.

In some embodiments provided herein are diet plans (also referred to asdiet regimens or regimens) for implementation in conjugation with themethods and formulations described herein. A diet plan described hereinis optionally included in a method and/or kit described herein. Incertain embodiments, a diet plan described herein is tailored for theindividual based on an understanding of the symptoms exhibited by theindividual. In some embodiments, a diet plan described herein works insynergy with a method and/or formulation described herein to achieve adesired result. In some embodiments, the desired result in a reductionor stabilization of blood glucose levels. In certain embodiments, thedesired result is a reduction or elimination of insulin administration.In certain embodiments, the desired result is a reduction in BMI. Incertain embodiments, the desired result is a reduction or elimination ofone or more symptoms of type II diabetes or an associated conditiondescribed herein.

Additional aspects and advantages of the present disclosure will becomereadily apparent to those skilled in this art from the followingdetailed description, wherein only illustrative embodiments of thepresent disclosure are shown and described. As will be realized, thepresent disclosure is capable of other and different embodiments, andits several details are capable of modifications in various obviousrespects, all without departing from the disclosure. Accordingly, thedrawings and description are to be regarded as illustrative in nature,and not as restrictive.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings or figures (also “FIG.” and “FIGS.” herein), ofwhich:

FIGS. 1A-1C provide summaries of clinical improvement in individualsdiagnosed with type II diabetes upon use of the dietary supplementformulations and methods described herein. FIG. 1A shows that in anexemplary case study, upon administration of dietary supplementformulations provided herein, insulin requirement was reduced from 30units daily to 10 units daily, and the requirement for insulin waseliminated after 4 months of administration of dietary supplementformulations provided herein. FIG. 1A also shows a significant drop inblood glucose levels as demonstrated by a two point drop in hemoglobinA1C upon four months of administration of formulations described herein.FIG. 1B shows that in another exemplary case study, upon administrationof dietary supplement formulations provided herein, the individual wasable to reduce insulin requirement, lost 20 lb without any additionalexercise and felt an improvement in foot pain and energy levels. FIG. 1Cshows that in a further exemplary case study, the individual was able toreduce insulin requirement within one week upon administration ofdietary supplement formulations provided herein. FIG. 1C alsodemonstrates that regular administration of dietary supplementformulations provided herein resulted in a two-fold reduction in bloodsugar levels, and elimination of requirements for cholesterol medicationand insulin.

FIG. 2 provides results of statistical survey of 151 diabeticindividuals who were administered formulations and diet plans describedherein.

DETAILED DESCRIPTION

While various embodiments of the invention have been shown and describedherein, it will be obvious to those skilled in the art that suchembodiments are provided by way of example only. Numerous variations,changes, and substitutions may occur to those skilled in the art withoutdeparting from the invention. It should be understood that variousalternatives to the embodiments of the invention described herein may beemployed. It shall be understood that different aspects of the inventioncan be appreciated individually, collectively, or in combination witheach other.

An object of the present disclosure is to provide dietary supplements,formulations and methods for administration to an individual with typeII diabetes or at risk of developing type II diabetes. Provided hereinare formulations and methods useful for treating, preventing,supporting, controlling, restoring, and/or maintaining blood sugarlevels in individuals with type II diabetes or at risk of developing thesame. Also provided are formulations and methods useful for reducingand/or eliminating requirement of ex-vivo insulin administration in anindividual diagnosed with type II diabetes.

Provided herein are methods and formulations of dietary supplements thatwhen administered to an individual treat, support and/or enhance atleast one of: detoxification, eyes and ears health, natural blood sugarmetabolism, male reproductive health, weight control, skin, soft tissue,skeletal tissue health, natural blood sugar levels, female reproductivehealth, healthy blood pressure levels, male sexual function health,glutathione levels, connective tissue health, triglyceride levels,circulatory system health, homocysteine levels, musculoskeletal health,LDL levels, antioxidant health, energy levels, reproductive health,natural pH levels, natural insulin response to glucose load, healthy HDLcholesterol levels, natural stress responses, natural glutathionelevels, natural growth and repair of tissues, natural biliary levels,natural glucose tolerance, adrenal function, natural insulin receptorsite sensitivity, platelet function, natural recovery time, brainfunction and memory, natural nerve transmission, heart andcardiovascular health, natural cell division, liver health, naturalbreakdown of fats, insulin health, natural bone growth, natural whiteblood cell levels, natural tryptophan metabolism, healthy red bloodcells, natural thermogenesis, small blood vessel health, natural ironand sugar utilization, health and integrity of cellular tissue, naturalsecretions of insulin and glucagon, the immune system health, naturalnutrient utilization, metabolism health, natural absorption of minerals,cardiovascular health, natural protein synthesis, kidney health, naturalproduction of nucleic acids, creatine phosphate, gall bladder health,natural heme production, muscle health, natural enzymatic reactions,bone health, healthy stress responses, oral health, methioninemetabolism, joint health, maintenance of a healthy nervous system,hormone health, appetite control, digestion health, glycemic control,colon health, gene expression, menstruation health, cellular repair,scalp health, nutrient transportation, intestinal health, adrenalhormones, respiratory health, chemical reactions, healthy hair, mucousmembranes, and nails and overall physical and mental well-being health.

Provided herein are methods and formulations of dietary supplements thatwhen administered to an individual treat, support and/or enhance atleast one of: neutralization of toxins, eyes and ears health, naturalblood sugar metabolism, male reproductive health, weight control,skin/soft tissue/skeletal tissue health, natural blood sugar levels,female reproductive health, healthy blood pressure levels, male sexualfunction health, beta cells of the pancreas, connective tissue health,removal of heavy metal toxins, circulatory system health, homocysteinelevels, musculoskeletal health, LDL levels, antioxidant health, energylevels, reproductive health, natural pH levels, natural cellular uptakeof glucose, healthy HDL cholesterol levels, natural stress responses,natural glutathione levels, natural growth and repair of tissues,natural biliary levels, natural glucose tolerance, adrenal function,natural insulin receptor site sensitivity, platelet function, naturalrecovery time, brain function and memory, natural nerve transmission,heart and cardiovascular health, natural cell division, liver health,natural breakdown of fats, insulin health, natural bone growth, naturalwhite blood cell levels, natural tryptophan metabolism, healthy redblood cells, natural thermogenesis, small blood vessel health, naturaliron and sugar utilization, health and integrity of cellular tissue,natural secretions of insulin and glucagon, the immune system health,natural nutrient utilization, metabolism health, natural absorption ofminerals, cardiovascular health, natural protein synthesis, kidneyhealth, natural production of nucleic acids, creatine phosphate, gallbladder health, natural heme production, muscle health, naturalenzymatic reactions, bone health, healthy stress responses, oral health,methionine metabolism, joint health, maintain a healthy nervous system,hormone health, appetite control, digestion health, glycemic control,colon health, gene expression, menstruation health, cellular repair,scalp health, nutrient transportation, intestinal health, adrenalhormones, beta cells of the pancreas, chemical reactions, healthyhair/mucous membranes/nails and physical and mental well-being. Incertain embodiments, the formulations and methods further comprise fishoils or derivatives thereof, administration of which enhances and/orsupports at least one of: heart health, cardiovascular health, immunesystem, natural liver function, natural hormones function, natural brainfunction, cell health, natural adrenal glands function, healthycholesterol levels, normal blood pressure levels and insulin health.

Provided herein are methods and formulations of dietary supplements thatwhen administered to an individual treat, support and/or enhance atleast one of: blood sugar metabolism, healthy hair/mucousmembranes/nails, weight control, adrenal function, natural blood sugarlevels, natural fat burning, healthy blood pressure levels, cognitivefunction, beta cells of the pancreas, eyes and ears health, triglyceridelevels, male reproductive health, natural white blood cell levels,female reproductive health, LDL levels, antioxidant health, energylevels, neuro protection, pH levels, cellular uptake of glucose, healthyHDL cholesterol levels, stamina, glutathione levels, glucokinaseactivity, natural biliary levels, GABA, natural hormone levels, naturalinsulin receptor site sensitivity, brain function and memory, naturalinsulin health, platelet function, natural adrenal hormones, heart andcardiovascular health, natural adrenal glands function, natural liverfunction, nutrient transportation, insulin health, digestion health,healthy red blood cells, glycemic control, colon health, healthy uricacid levels, small blood vessel health, gene expression,gastrointestinal health, physical and mental well-being health, hormonehealth, maintain a healthy nervous system, health and integrity ofcellular tissue, natural secretions of insulin and glucagon, the immunesystem health, joint health, healthy metabolic processes, secretions ofinsulin and glucagon, glucose tolerance, natural enzymatic reactions,tryptophan metabolism, intestinal health, kidney health, cartilage,thyroid health, peripheral glucose utilization, muscle health, naturalinsulin production, bone health, natural stress responses, oral health,methionine metabolism, the manufacture and utilization ofcarbohydrates/fats/amino acids, and formation offats/proteins/carbohydrates/amino acids/antibiotics. In certainembodiments, the formulations and methods further comprise fish oils orderivatives thereof, administration of which enhances and/or supports atleast one of: heart health, cardiovascular health, immune system,natural liver function, natural hormones function, natural brainfunction, cell health, natural adrenal glands function, healthycholesterol levels, normal blood pressure levels and insulin health.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as is commonly understood by one of skill in theart to which the claimed subject matter belongs.

It is to be understood that the foregoing general description and thefollowing detailed description are exemplary and explanatory only andare not restrictive of any subject matter claimed. In this application,the use of the singular includes the plural unless specifically statedotherwise.

In the present description, any concentration range, percentage range,ratio range, or integer range is to be understood to include the valueof any integer within the recited range and, when appropriate, fractionsthereof (such as one tenth and one hundredth of an integer), unlessotherwise indicated. As used herein, “about” means ±10% of the indicatedrange, value, sequence, or structure, unless otherwise indicated. Itshould be understood that the terms “a” and “an” as used herein refer to“one or more” of the enumerated components unless otherwise indicated ordictated by its context. The use of the alternative (e.g., “or”) shouldbe understood to mean either one, both, or any combination thereof ofthe alternatives. As used herein, the terms “include” and “comprise” areused synonymously.

It is to be understood that the methods, formulations and compositionsdescribed herein are not limited to the particular methodology,protocols, methods, and reagents described herein and as such may vary.It is also to be understood that the terminology used herein is for thepurpose of describing particular embodiments only, and is not intendedto limit the scope of the methods and compositions described herein,which will be limited only by the appended claims.

Exemplary Ingredients

The methods, dietary supplements and formulations described herein maycomprise at least one of the ingredients discussed below. In certainembodiments, formulations described herein comprise a plurality ofingredients described below. In certain embodiments, two or moreingredients are combined in an amount suitable to provide synergisticeffects. Formulations and dietary supplements described herein maycontain other active and inactive ingredients in addition to one or moreingredients described herein.

Biotin: Alternatively called vitamin H or coenzyme R a water-solubleB-vitamin (vitamin B₇). Certain methods and formulations describedherein comprise a suitable amount of biotin or derivative or analogthereof. In certain embodiments, methods and formulations of dietarysupplements comprise biotin or derivative or analog thereof in an amountsuitable to support and/or enhance at least one of: blood sugar control,cholesterol levels, insulin response to glucose load, manufacture andutilization of carbohydrates/fats/amino acids, maintenance of insulinreceptor site sensitivity, glucokinase activity, hair growth, nailhealth and metabolism.

Chromium Picloinate: In some embodiments, the source of chromium ischromium polynicotinate. Certain methods and formulations describedherein comprise a suitable amount of chromium piclionate or derivativeor analog thereof, including for instance any type of chromium. Incertain embodiments, methods and formulations of dietary supplementscomprise chromium piclionate or derivative or analog thereof in anamount suitable to support and/or enhance at least one of: blood sugarlevel, cholesterol level, optimizing the impact of insulin on insulinreceptor sites, thermogenesis, healthy triglyceride levels, healthy HDLcholesterol, metabolism, regulating food cravings and normal bloodpressure.

Vitamin A: is a group of unsaturated nutritional organic compounds, thatincludes retinol, retinal, retinoic acid, and several provitamin Acarotenoids, among which beta-carotene is the most important. Certainmethods and formulations described herein comprise a suitable amount ofvitamin A or derivative or analog thereof. In certain embodiments,methods and formulations of dietary supplements comprise vitamin A orderivative or analog thereof in an amount suitable to support and/orenhance at least one of: eye health, healthy vision, cofactors for toxinbreakdown, homocysteine levels, moisture levels for eyes/skin/mucousmembranes, antioxidant levels, heart health, skin/soft tissue/skeletaltissue health.

Vitamin C or L-ascorbic acid, or ascorbate: Certain methods andformulations described herein comprise a suitable amount of vitamin C orderivative or analog thereof. In certain embodiments, methods andformulations of dietary supplements comprise vitamin C or derivative oranalog thereof in an amount suitable to support and/or enhance at leastone of: neutralization of toxins, glutathione levels, immune system,removal of heavy metal toxins, blood sugar metabolism, beta cells of thepancreas, antioxidation, and growth and repair of tissues

Vitamin D: In some embodiments, the source of Vitamin D is vitamin D3(also known as cholecalciferol). In some embodiments, the source ofVitamin D is vitamin D2 (ergocalciferol). Certain methods andformulations described herein comprise a suitable amount of vitamin D orderivative or analog thereof. In certain embodiments, methods andformulations of dietary supplements comprise vitamin D or derivative oranalog thereof in an amount suitable to support and/or enhance at leastone of: blood sugar metabolism, heart and cardiovascular health, immunefunction, insulin receptor site activity, bone health, reducing the riskof some forms of cancer, alleviating musculoskeletal pain

Vitamin E: In some embodiments the source of Vitamin E is a tocopherol.In some embodiments, the source of Vitamin E is a tocotrienol. In someembodiments, tocopherol is 7-tocopherol. In some embodiments, tocopherolis α-tocopherol. In some embodiments, the source of Vitamin E isα-tocopherol succinate. Certain methods and formulations describedherein comprise a suitable amount of vitamin E or derivative or analogthereof. In certain embodiments, methods and formulations of dietarysupplements comprise vitamin E or derivative or analog thereof in anamount suitable to support and/or enhance at least one of: free radicalelimination, health and integrity of cellular tissue, healthy insulinreceptor site activity, triglyceride levels, LDL levels, plateletfunction, glycemic control, antioxidant levels, and immune function.

Vitamin B1: In some embodiments, the source of Vitamin B1 is thiamine(or thiamin). In some embodiments, the source of Vitamin B1 is thiaminehydrochloride. In some embodiments, the source of vitamin B1 isBenfotiamine. Certain methods and formulations described herein comprisea suitable amount of vitamin B1 or derivative or analog thereof. Incertain embodiments, methods and formulations of dietary supplementscomprise vitamin B1 or derivative or analog thereof in an amountsuitable to support and/or enhance at least one of: cofactor levels forenergy production, antioxidation, neuro-protection, small blood vesselhealth, blood sugar metabolism, cholesterol levels, energy production,heart and cardiovascular health, and brain function and memory.

Vitamin B2 or riboflavin: Certain methods and formulations describedherein comprise a suitable amount of vitamin B2 or derivative or analogthereof. In certain embodiments, methods and formulations of dietarysupplements comprise vitamin B2 or derivative or analog thereof in anamount suitable to support and/or enhance at least one of:antioxidation, energy production, immune function, energy levels,maintenance of healthy hair, skin, mucous membranes, and nails,reproductive function, liver and memory.

Niacin also known as vitamin B₃ or nicotinic acid: Certain methods andformulations described herein comprise a suitable amount of niacin orderivative or analog thereof. In certain embodiments, methods andformulations of dietary supplements comprise niacin or derivative oranalog thereof in an amount suitable to support and/or enhance at leastone of: energy production, oxidation, cholesterol levels, blood sugarmetabolism, beta cells of the pancreas, adrenal function, support andmaintenance of a healthy nervous system, one or more metabolicprocesses, and healthy cardiovascular function.

Vitamin B6: In some embodiments, the source of Vitamin B6 is Pyridoxal5′-phosphate (PLP).: In some embodiments, the source of Vitamin B6 ispyridoxine. Certain methods and formulations described herein comprise asuitable amount of vitamin B6 or derivative or analog thereof. Incertain embodiments, methods and formulations of dietary supplementscomprise vitamin B6 or derivative or analog thereof in an amountsuitable to support and/or enhance at least one of: antioxidation,energy production, homocysteine levels, blood sugar metabolism, glucosetolerance, secretions of insulin and glucagon, tryptophan metabolism andneuro-protection.

Vitamin B12 also called cobalamin: In some embodiments the source ofvitamin B12 is methylcobalamin. In some embodiments, the source ofVitamin B12 is cyanocobalamin. Certain methods and formulationsdescribed herein comprise a suitable amount of vitamin B12 or derivativeor analog thereof. In certain embodiments, methods and formulations ofdietary supplements comprise vitamin B12 or derivative or analog thereofin an amount suitable to support and/or enhance at least one of: healthyhomocysteine levels, healthy red blood cells, energy production, immunesystem and neuro-protection.

Magnesium: In some embodiments, the source of magnesium is magnesiumcitrate. In some embodiments, the source of magnesium is magnesiumglycinate. Certain methods and formulations described herein comprise asuitable amount of magnesium or derivative or analog thereof. In certainembodiments, methods and formulations of dietary supplements comprisemagnesium or derivative or analog thereof in an amount suitable tosupport and/or enhance at least one of: mood stabilization, musclehealth, blood pressure, cardiovascular system, bone health, metabolism,blood sugar levels, insulin receptor site sensitivity, cholesterollevels and platelet activity.

Ginseng: In some embodiments, the ginseng is Asian or Korean ginseng(Panax ginseng). In some embodiments, the ginseng is American ginseng(Panax quinquefolius). Certain methods and formulations described hereincomprise a suitable amount of ginseng or derivative or analog thereof.In certain embodiments, methods and formulations of dietary supplementscomprise ginseng or derivative or analog thereof in an amount suitableto support and/or enhance at least one of: immune function, carbohydrateabsorption by the intestines, blood sugar metabolism, insulinproduction, menstruation, weight control, physical and mental well-beingand male sexual function

Fenugreek: Certain methods and formulations described herein comprise asuitable amount of fenugreek or derivative or analog thereof. In certainembodiments, methods and formulations of dietary supplements comprisefenugreek or derivative or analog thereof in an amount suitable tosupport and/or enhance at least one of: blood sugar metabolism, insulinsensitivity, cholesterol levels, insulin production, minerals inclusiveof iron, potassium, calcium, selenium, copper, zinc, manganese, andmagnesium, thiamin, folic acid, riboflavin, pyridoxine (vitamin B6),niacin, and vitamins A and C, LDL levels and mental aging.

Holy Basil Leaf also known as Ocimum sanctum, Ocimum tenuifloru orluisi: Certain methods and formulations described herein comprise asuitable amount of holy basil leaf or derivative or analog thereof. Incertain embodiments, methods and formulations of dietary supplementscomprise holy basil leaf or derivative or analog thereof in an amountsuitable to support and/or enhance at least one of: blood sugarmetabolism, stress responses, immune responses, platelet activity,cholesterol levels, storage of glucose as glycogen, adaptogen andtherefore supports healthy stress responses, and support forgastro-intestinal health.

Bitter Melon: Certain methods and formulations described herein comprisea suitable amount of bitter melon or derivative or analog thereof. Incertain embodiments, methods and formulations of dietary supplementscomprise bitter melon or derivative or analog thereof in an amountsuitable to support and/or enhance at least one of: blood sugarmetabolism, pancreatic beta cells, gastro-intestinal health, and liverfunction.

Gymnema also known as Gymnema Sylvestre: Certain methods andformulations described herein comprise a suitable amount of gymnema orderivative or analog thereof. In certain embodiments, methods andformulations of dietary supplements comprise gymnema or derivative oranalog thereof in an amount suitable to support and/or enhance at leastone of: blood sugar metabolism, sugar cravings, insulin responses,insulin receptor site sensitivity, cholesterol levels, weight loss,digestion, and pancreatic beta cells.

Prickly Pear Cactus (Nopal): Certain methods and formulations describedherein comprise a suitable amount of prickly pear cactus or derivativeor analog thereof. In certain embodiments, methods and formulations ofdietary supplements comprise prickly pear cactus or derivative or analogthereof in an amount suitable to support and/or enhance at least one of:blood sugar metabolism and regulation of cholesterol levels.

Cinammon: Certain methods and formulations described herein comprise asuitable amount of cinammon or derivative or analog thereof. In certainembodiments, methods and formulations of dietary supplements comprisecinnamon or derivative or analog thereof in an amount suitable tosupport and/or enhance at least one of: blood sugar metabolism,digestion, appetite normalization, alleviation of fungal infection, andcholesterol levels.

Vanadium: Certain methods and formulations described herein comprise asuitable amount of vanadium or derivative or analog thereof. In certainembodiments, methods and formulations of dietary supplements comprisevanadium or derivative or analog thereof in an amount suitable tosupport and/or enhance at least one of: blood sugar metabolism,cholesterol levels, heart health and water retention. In someembodiments, the source of vanadium is vanadium sulfate.

Lipoic Acid: Certain methods and formulations described herein comprisea suitable amount of Lipoic Acid or derivative or analog thereof. Incertain embodiments, methods and formulations of dietary supplementscomprise Lipoic Acid or derivative or analog thereof in an amountsuitable to support and/or enhance at least one of: blood sugarmetabolism, enzymatic reactions in the body, insulin sensitivity,mediation of oxidative stress, liver, bone health, eye health,neurological system, skin, blood pressure, cholesterol and weightregulation. In some embodiments, lipoic acid is R-lipoic acid.

Zinc: Certain methods and formulations described herein comprise asuitable amount of zinc or derivative or analog thereof. In certainembodiments, methods and formulations of dietary supplements comprisezinc or derivative or analog thereof in an amount suitable to supportand/or enhance at least one of: immune function, cell division, hormonelevels, antioxidation, healthy stress responses, red blood cells, whiteblood cells, male reproductive health, female reproductive health,cardiovascular system, blood sugar metabolism, brain health, cholesterolstabilization and mood stabilization. In some embodiments, the source ofzinc is zinc glycinate. In some embodiments the source of zinc is zincL-monomethionine.

Calcium: Certain methods and formulations described herein comprise asuitable amount of calcium or derivative or analog thereof. In certainembodiments, methods and formulations of dietary supplements comprisecalcium or derivative or analog thereof in an amount suitable to supportand/or enhance at least one of: bone health, nerve transmission, bloodsugar metabolism, oral health, weight regulation, colon health, musclehealth, heart health, normal blood pressure, blood sugar metabolism,joint health, kidney health, pH level, and nutrient transportation. Insome embodiments calcium is calcium ascorbate. In some embodimentcalcium is calcium citrate malate.

Selenium: Certain methods and formulations described herein comprise asuitable amount of selenium or derivative or analog thereof. In certainembodiments, methods and formulations of dietary supplements compriseselenium or derivative or analog thereof in an amount suitable tosupport and/or enhance at least one of: thyroid health, DNA synthesis,immune function, reproduction, blood sugar metabolism, antioxidation,and bone growth. In some embodiments, the source of selenium isL-selenomethionine.

Artichoke extract: Certain methods and formulations described hereincomprise a suitable amount of artichoke extract or derivative or analogthereof. In certain embodiments, methods and formulations of dietarysupplements comprise artichoke extract or derivative or analog thereofin an amount suitable to support and/or enhance at least one of:cholesterol, heart function, liver function, blood sugar metabolism,antioxidation, digestion, and apoptosis.

Ginkgo Biloba: Certain methods and formulations described hereincomprise a suitable amount of gingko biloba, extract or derivative oranalog thereof. In certain embodiments, methods and formulations ofdietary supplements comprise gingko biloba, extract or derivative oranalog thereof in an amount suitable to support and/or enhance at leastone of: platelet function, memory, blood flow to the brain, oxygenutilization, vision, eyes, and mood stabilization.

Vitamin B5. In some embodiments, the source of Vitamin B5 is PantothenicAcid. In some embodiments the source of vitamin B5 is calciumpantothenate. In some embodiments, the source of Vitamin B5 ispantethine. Certain methods and formulations described herein comprise asuitable amount of Vitamin B5 or derivative or analog thereof. Incertain embodiments, methods and formulations of dietary supplementscomprise Vitamin B5 or derivative or analog thereof in an amountsuitable to support and/or enhance at least one of: acetylcholine, hair,mood stabilization, stress responses, heart health, immune health, jointhealth, adrenal hormones, formation of fats/proteins/carbohydrates/aminoacids/antibiotics, and stamina.

Phosphorus: Certain methods and formulations described herein comprise asuitable amount of phosphorous or derivative or analog thereof. Incertain embodiments, methods and formulations of dietary supplementscomprise phosphorus or derivative or analog thereof in an amountsuitable to support and/or enhance at least one of: bone, digestion,hormones, energy, cellular repair, chemical reactions, proper nutrientutilization, kidneys, brain support and protein formation. In someembodiments, the source of phosphorus is disodium phosphate.

Copper: Certain methods and formulations described herein comprise asuitable amount of copper or derivative or analog thereof. In certainembodiments, methods and formulations of dietary supplements comprisecopper or derivative or analog thereof in an amount suitable to supportand/or enhance at least one of: joint health, proper growth, connectivetissues, brain, enzymatic reactions, iron and sugar utilization, energyproduction, thyroid health, red blood cell formation, immune system, andhealthy cholesterol levels. In some embodiments, the source of copper iscopper gluconate.

Manganese: Certain methods and formulations described herein comprise asuitable amount of manganese or derivative or analog thereof. In certainembodiments, methods and formulations of dietary supplements comprisemanganese or derivative or analog thereof in an amount suitable tosupport and/or enhance at least one of: GABA, bones, antioxidation,blood sugar metabolism, overall metabolism, inflammation alleviation,thyroid, absorption, brain, nervous system and digestion. In someembodiments, the source of manganese is manganese gluconate.

Molybdenum: Certain methods and formulations described herein comprise asuitable amount of molybdenum or derivative or analog thereof. Incertain embodiments, methods and formulations of dietary supplementscomprise molybdenum or derivative or analog thereof in an amountsuitable to support and/or enhance at least one of: uric acidstabilization, sulfation, enzyme levels, inflammation alleviation, anddetoxification. In some embodiments the source of molybdenum ismolybdenum amino acid chelate.

Trimethylglycine: Certain methods and formulations described hereincomprise a suitable amount of trimethylglycine or derivative or analogthereof. In certain embodiments, methods and formulations of dietarysupplements comprise trimethylglycine or derivative or analog thereof inan amount suitable to support and/or enhance at least one of: methioninemetabolism, homocysteine levels and liver function.

Evening Primrose Oil also known as Cis-Linoleic Acid: Certain methodsand formulations described herein comprise a suitable amount of eveningprimrose oil or derivative or analog thereof. In certain embodiments,methods and formulations of dietary supplements comprise eveningprimrose oil or derivative or analog thereof in an amount suitable tosupport and/or enhance at least one of: skin health and function,inflammation alleviation, mmenstruation, neuro-protection, memory,nails, scalp, and hair, prostaglandin E2, and gastro-intestinal tract.

Inulin: Certain methods and formulations described herein comprise asuitable amount of inulin or derivative or analog thereof. In certainembodiments, methods and formulations of dietary supplements compriseinulin or derivative or analog thereof in an amount suitable to supportand/or enhance at least one of: intestinal health, immune system,short-chain fatty acids, liver, cardiovascular functions, absorption ofminerals and digestion.

Medium Chain Triglycerides: Certain methods and formulations describedherein comprise a suitable amount of medium chain triglycerides orderivative or analog thereof. In certain embodiments, methods andformulations of dietary supplements comprise medium chain triglyceridesor derivative or analog thereof in an amount suitable to support and/orenhance at least one of: absorption, energy, weight control, appetitecontrol, cardiovascular system, and immune system.

Quercetin, also known as 3,3′,4′5,7-Pentahydroxyflavone, bioflavonoid,bioflavonoid complex, bioflavonoid concentrate, bioflavonoid extract: Insome embodiments, the source of quercetin is quercetin dihydrate.Certain methods and formulations described herein comprise a suitableamount of quercetin or derivative or analog thereof. In certainembodiments, methods and formulations of dietary supplements comprisequercetin or derivative or analog thereof in an amount suitable tosupport and/or enhance at least one of: antioxidation, inflammationalleviation, histamine regulation, respiratory health, cardiovascularsystem, blood pressure regulation and stress management.

Rutin, also called rutoside, quercetin-3-O-rutinoside and sophorin:Certain methods and formulations described herein comprise a suitableamount of rutin or derivative or analog thereof. In certain embodiments,methods and formulations of dietary supplements comprise rutin orderivative or analog thereof in an amount suitable to support and/orenhance at least one of: antioxidation, inflammation alleviation,utilization of vitamin C, high blood pressure regulation, hemorrhoidalleviation, cholesterol and blood vessel health.

Hesperidin: Certain methods and formulations described herein comprise asuitable amount of hersperidin or derivative or analog thereof. Incertain embodiments, methods and formulations of dietary supplementscomprise hersperidin or derivative or analog thereof in an amountsuitable to support and/or enhance at least one of: antioxidation,inflammation alleviation, blood pressure regulation, and blood vesselhealth.

Milk thistle, also known as silybum marianum, or silymarin: Certainmethods and formulations described herein comprise a suitable amount ofmilk thistle or extract or derivative or analog thereof. In certainembodiments, methods and formulations of dietary supplements comprisemilk thistle or extract or derivative or analog thereof in an amountsuitable to support and/or enhance at least one of: bile levels, biliarycholesterol levels, bile saturation index, antioxidation, detoxificationpathways, inflammation alleviation and protein synthesis.

Taurine also known as 2-aminoethanesulfonic acid: In some embodiment thesource of taurine is L-taurine. Certain methods and formulationsdescribed herein comprise a suitable amount of taurine or derivative oranalog thereof. In certain embodiments, methods and formulations ofdietary supplements comprise taurine or derivative or analog thereof inan amount suitable to support and/or enhance at least one of: obesitymanagement, blood sugar metabolism, heart health, life-spanimprovements, eyes and ears health, liver health, cardiovascular system,insulin action, antioxidation, calcium, magnesium, potassium, sodium,blood pressure, platelet activity, bile acids and cholesterol.

Choline: In some embodiments, the source of choline is cholinebitartrate. Certain methods and formulations described herein comprise asuitable amount of choline or derivative or analog thereof. In certainembodiments, methods and formulations of dietary supplements comprisecholine or derivative or analog thereof in an amount suitable to supportand/or enhance at least one of: liver function, moods, memory,endurance, and cholesterol levels.

Betaine Hydrochloride: Certain methods and formulations described hereincomprise a suitable amount of betaine hydrochloride or derivative oranalog thereof. In certain embodiments, methods and formulations ofdietary supplements comprise betaine hydrochloride or derivative oranalog thereof in an amount suitable to support and/or enhance at leastone of: digestion and gall bladder function.

Marshmallow root: Certain methods and formulations described hereincomprise a suitable amount of marshmallow root or extract or derivativeor analog thereof. In certain embodiments, methods and formulations ofdietary supplements comprise marshmallow root or extract or derivativeor analog thereof in an amount suitable to support and/or enhance atleast one of: inflammation alleviation, intestinal and digestive health.

Curcumin: Certain methods and formulations described herein comprise asuitable amount of curcumin or derivative or analog thereof. In certainembodiments, methods and formulations of dietary supplements comprisecurcumin or derivative or analog thereof in an amount suitable tosupport and/or enhance at least one of: inflammation response,antioxidation, liver and brain health, immune system, dopanergic neuronsand neuro-protection

L-glutamine: Certain methods and formulations described herein comprisea suitable amount of L-glutamine or derivative or analog thereof. Incertain embodiments, methods and formulations of dietary supplementscomprise L-glutamine or derivative or analog thereof in an amountsuitable to support and/or enhance at least one of: sulfation,methylation, detoxification, glutathione storage, oxidative stressmanagement and small intestine health.

N-Acetyl-L-Cysteine: Certain methods and formulations described hereincomprise a suitable amount of N-Acetyl-L-Cystine or derivative or analogthereof. In certain embodiments, methods and formulations of dietarysupplements comprise N-Acetyl-L-Cystine or derivative or analog thereofin an amount suitable to support and/or enhance at least one of:glutathione level management, gene expression, inflammation alleviation,antioxidation and insulin receptor site sensitivity.

Ginger root: Certain methods and formulations described herein comprisea suitable amount of ginger root or extract or derivative or analogthereof. In certain embodiments, methods and formulations of dietarysupplements comprise ginger root or extract or derivative or analogthereof in an amount suitable to support and/or enhance at least one of:bile secretion, liver cholesterol levels, inflammation alleviation,blood sugar metabolism, cholesterol management, insulin levels, insulinsensitivity, digestion, heart health, and weight management.

Bromelain: Certain methods and formulations described herein comprise asuitable amount of bromelian or derivative or analog thereof. In certainembodiments, methods and formulations of dietary supplements comprisebromelain or derivative or analog thereof in an amount suitable tosupport and/or enhance at least one of: digestion, inflammationalleviation, recovery time, and joint health

Methyl sulfonyl methane (MSM): Certain methods and formulationsdescribed herein comprise a suitable amount of MSM or derivative oranalog thereof. In certain embodiments, methods and formulations ofdietary supplements comprise MSM or derivative or analog thereof in anamount suitable to support and/or enhance at least one of: inflammationalleviation, sulfation and liver-gut axis health.

S-Adenosyl Methionine (sam-E): Certain methods and formulationsdescribed herein comprise a suitable amount of sam-E or derivative oranalog thereof. In certain embodiments, methods and formulations ofdietary supplements comprise sam-E or derivative or analog thereof in anamount suitable to support and/or enhance at least one of: moodstabilization, brain, liver, joints support.

Dandelion root: Certain methods and formulations described hereincomprise a suitable amount of dandelion root or extract or derivative oranalog thereof. In certain embodiments, methods and formulations ofdietary supplements comprise dandelion root or extract or derivative oranalog thereof in an amount suitable to support and/or enhance at leastone of: liver, gall bladder, bile function, digestion and cholesterollevel.

Lecithin: Certain methods and formulations described herein comprise asuitable amount of lecithin or derivative or analog thereof. In certainembodiments, methods and formulations of dietary supplements compriselecithin or derivative or analog thereof in an amount suitable tosupport and/or enhance at least one of: biliary system, lipids, nervoussystem, circulatory system, metabolism, heart health, and memory.

Beet root: Certain methods and formulations described herein comprise asuitable amount of beet root or extract or derivative or analog thereof.In certain embodiments, methods and formulations of dietary supplementscomprise beet root or extract or derivative or analog thereof in anamount suitable to support and/or enhance at least one of: bloodpressure, stamina, inflammation management, and detoxification.

Superoxide Dismutase: Certain methods and formulations described hereincomprise a suitable amount of superoxide dismutase or derivative oranalog thereof. In certain embodiments, methods and formulations ofdietary supplements comprise superoxide dismutase or derivative oranalog thereof in an amount suitable to support and/or enhance at leastone of: antioxidation, and inflammation management.

Sarsparilla root: Certain methods and formulations described hereincomprise a suitable amount of sarsparilla root or extract or derivativeor analog thereof. In certain embodiments, methods and formulations ofdietary supplements comprise sarsparilla root or extract or derivativeor analog thereof in an amount suitable to support and/or enhance atleast one of: skin, kidney, detoxification and inflammation alleviation.

DL-Methionine: Certain methods and formulations described hereincomprise a suitable amount of DL-methionine or derivative or analogthereof. In certain embodiments, methods and formulations of dietarysupplements comprise DL-methionine or derivative or analog thereof in anamount suitable to support and/or enhance at least one of: liver,breakdown of fats and antioxidation.

Gotu Kola: Certain methods and formulations described herein optionallycomprise a suitable amount of gotu kola or extract or derivative oranalog thereof. In certain embodiments, methods and formulations ofdietary supplements comprise gota kola or extract or derivative oranalog thereof in an amount suitable to support and/or enhance at leastone of: detoxification, liver and venous system health.

L-glutathione: Certain methods and formulations described hereincomprise a suitable amount of L-glutathione or derivative or analogthereof. In certain embodiments, methods and formulations of dietarysupplements comprise L-glutathione or derivative or analog thereof in anamount suitable to support and/or enhance at least one of: heartfunctioning and health, cardiovascular system, detoxification, liverhealth, mood stabilization, respiratory system, antioxidation, andinflammation alleviation.

L-Glycine: Certain methods and formulations described herein comprise asuitable amount of L-glycine or derivative or analog thereof. In certainembodiments, methods and formulations of dietary supplements compriseL-glycine or derivative or analog thereof in an amount suitable tosupport and/or enhance at least one of: production of nucleic acids,bile acids, creatine phosphate; breakdown of fats; heme production; moodstabilization; blood sugar metabolism; muscle growth; hormones and hearthealth.

Watercress Leaf: Certain methods and formulations described hereincomprise a suitable amount of watercress leaf or extract or derivativeor analog thereof. In certain embodiments, methods and formulations ofdietary supplements comprise watercress leaf or extract or derivative oranalog thereof in an amount suitable to support and/or enhance at leastone of: antioxidation and DNA against damage.

Banaba Leaf: Certain methods and formulations described herein comprisea suitable amount of banaba leaf or extract or derivative or analogthereof. In certain embodiments, methods and formulations of dietarysupplements comprise banaba leaf or extract or derivative or analogthereof in an amount suitable to support and/or enhance at least one of:blood sugar metabolism, peripheral glucose utilization, weight control,cholesterol maintenance, insulin sensitivity, cellular uptake ofglucose, triglyceride levels, antioxidation, inflammation response andbone health.

Berberine Hydrochloride: Certain methods and formulations describedherein comprise a suitable amount of berberine hydrochloride orderivative or analog thereof. In certain embodiments, methods andformulations of dietary supplements comprise berberine hydrochloride orderivative or analog thereof in an amount suitable to support and/orenhance at least one of: blood sugar metabolism, weight management,cholesterol, triglycerides, cognitive function, heart health,cardiovascular, cartilage and bone health, neuroprotection, inflammationalleviation and intestinal health.

Bitter Melon: Certain methods and formulations described herein comprisea suitable amount of bitter melon or extract or derivative or analogthereof. In certain embodiments, methods and formulations of dietarysupplements comprise bitter melon or extract or derivative or analogthereof in an amount suitable to support and/or enhance at least one of:blood sugar levels/metabolism, cholesterol and weight management,triglycerides, antioxidation and digestion.

Citrimax: Certain methods and formulations described herein comprise asuitable amount of citrimax or extract or derivative or analog thereof.In certain embodiments, methods and formulations of dietary supplementscomprise citrimax or extract or derivative or analog thereof in anamount suitable to support and/or enhance at least one of: weight lossand appetite control.

Guggul: Certain methods and formulations described herein comprise asuitable amount of guggul or extract or derivative or analog thereof. Incertain embodiments, methods and formulations of dietary supplementscomprise guggul or extract or derivative or analog thereof in an amountsuitable to support and/or enhance at least one of: blood sugarlevels/metabolism, cholesterol and weight management, triglycerides,antioxidation and digestion, thyroid health, LDL levels, lipidperoxidation and cholesterol maintenance.

Poria Cocos Root: Certain methods and formulations described hereincomprise a suitable amount of poria cocos root or extract or derivativeor analog thereof. In certain embodiments, methods and formulations ofdietary supplements comprise poria cocos root or extract or derivativeor analog thereof in an amount suitable to support and/or enhance atleast one of: inflammation alleviation, gastrointestinal health, moodstabilization, water retention (diuretic), and central nervous systemmaintenance.

Rehmannia Glutinosa or Chinese Foxglove: Certain methods andformulations described herein comprise a suitable amount of rehmanniaglutinosa or extract or derivative or analog thereof. In certainembodiments, methods and formulations of dietary supplements compriserehmannia glutinosa or extract or derivative or analog thereof in anamount suitable to support and/or enhance at least one of: inflammationalleviation, blood sugar metabolism, red blood cell formation, kidneys,and energy.

Broad Bean: Certain methods and formulations described herein optionallycomprise a suitable amount of broad bean or extract or derivative oranalog thereof. In certain embodiments, methods and formulations ofdietary supplements comprise broad bean or extract or derivative oranalog thereof in an amount suitable to support and/or enhance at leastone of: antioxidation support, dopamine, and cholesterol maintenance.

Inositol or cyclohexane-1,2,3,4,5,6-hexol: Certain methods andformulations described herein comprise a suitable amount of inositol orderivative or analog thereof. In certain embodiments, methods andformulations of dietary supplements comprise inositol or derivative oranalog thereof in an amount suitable to support and/or enhance at leastone of: neuroprotection, hair health, cholesterol stabilization, moodstabilization, blood sugar metabolism, and digestion.

L-Carnitine tartrate: Certain methods and formulations described hereincomprise a suitable amount of L-carnitine tartrate or derivative oranalog thereof. In certain embodiments, methods and formulations ofdietary supplements comprise L-carnitine tartrate or derivative oranalog thereof in an amount suitable to support and/or enhance at leastone of: heart health, cardiovascular system, fat burning, brain, fattyliver alleviation, insulin sensitivity, blood sugar metabolism,neuroprotection and cholesterol maintenance.

Para-aminobenzoic acid (PABA): Certain methods and formulationsdescribed herein comprise a suitable amount of PABA or derivative oranalog thereof. In certain embodiments, methods and formulations ofdietary supplements comprise PABA or derivative or analog thereof in anamount suitable to support and/or enhance at least one of: antioxidationand utilization of B5.

Asiatic Dogwood Fruit: Certain methods and formulations described hereincomprise a suitable amount of asiatic dogwood fruit or extract orderivative or analog thereof. In certain embodiments, methods andformulations of dietary supplements comprise asiatic dogwood fruit orextract or derivative or analog thereof in an amount suitable to supportand/or enhance at least one of: inflammation control, antioxidation,cholesterol maintenance, liver and kidney health, cardiovascular health,menstruation, immune system regulation and blood sugar metabolism.

Cordyceps: Certain methods and formulations described herein comprise asuitable amount of cordyceps or extract or derivative or analog thereof.In certain embodiments, methods and formulations of dietary supplementscomprise cordyceps or extract or derivative or analog thereof in anamount suitable to support and/or enhance at least one of: cholesterolstabilization, cellular repair, DNA repair, liver and kidney health,immune system health, antioxidation and energy.

Maca also known as Peruvian Ginseng: Certain methods and formulationsdescribed herein comprise a suitable amount of maca or extract orderivative or analog thereof. In certain embodiments, methods andformulations of dietary supplements comprise maca or extract orderivative or analog thereof in an amount suitable to support and/orenhance at least one of: stress management, and mood stabilization.

Suma root: Certain methods and formulations described herein comprise asuitable amount of suma root or extract or derivative or analog thereof.In certain embodiments, methods and formulations of dietary supplementscomprise suma root or extract or derivative or analog thereof in anamount suitable to support and/or enhance at least one of: blood sugarmetabolism, adaptogenic/stress, adrenal glands, hormones, blood sugarmetabolism, energy, heart health and inflammation alleviation.

Aswagandha Root, also known as Withania somnifera: Certain methods andformulations described herein comprise a suitable amount of aswagandharoot or extract or derivative or analog thereof. In certain embodiments,methods and formulations of dietary supplements comprise aswagandha rootor extract or derivative or analog thereof in an amount suitable tosupport and/or enhance at least one of: stress reduction, adrenal glandsfunction, liver, antioxidation, thyroid and healthy cortisol levels.

Rhodiola Rosea: Certain methods and formulations described hereincomprise a suitable amount of rhodiola rosea or extract or derivative oranalog thereof. In certain embodiments, methods and formulations ofdietary supplements comprise rhodiola rosea or extract or derivative oranalog thereof in an amount suitable to support and/or enhance at leastone of: central nervous system, mood stabilization, heart health,cardiovascular health, healthy stress response, immune system, cognitivefunction, and mental energy.

Eleutherococcus Senticosus: Certain methods and formulations describedherein comprise a suitable amount of eleutherococcus senticosus orextract or derivative or analog thereof. In certain embodiments, methodsand formulations of dietary supplements comprise eleutherococcussenticosus or extract or derivative or analog thereof in an amountsuitable to support and/or enhance at least one of: stress management,energy, LDL cholesterol, and adrenal feedback loop.

Pantethine: Certain methods and formulations described herein comprise asuitable amount of pantethine or extract or derivative or analogthereof. In certain embodiments, methods and formulations of dietarysupplements comprise pantetheine or extract or derivative or analogthereof in an amount suitable to support and/or enhance at least one of:adrenals, adrenal hormones, stress, and cortisol.

Salacia oblonga: Certain methods and formulations described hereincomprise a suitable amount of salacia oblonga or extract or derivativeor analog thereof. In certain embodiments, methods and formulations ofdietary supplements comprise salacia oblonga or extract or derivative oranalog thereof in an amount suitable to support and/or enhance at leastone of: blood sugar metabolism, joint health, menstruation, and weightmanagement.

Phosphatidyl Serine: Certain methods and formulations described hereincomprise a suitable amount of phosphatidyl serine or derivative oranalog thereof. In certain embodiments, methods and formulations ofdietary supplements comprise phosphatidyl serine or derivative or analogthereof in an amount suitable to support and/or enhance at least one of:cellular chemical signaling, brain health, hippocampus function, stressalleviation, HPA axis, cortisol levels, and sleep.

Eicosapentaenoic acid and Docosahexaenoic acid (EPA/DHA): Certainmethods and formulations described herein comprise a suitable amount ofEPA/DHA or derivative or analog thereof. In certain embodiments, methodsand formulations of dietary supplements comprise EPA/DHA or derivativeor analog thereof in an amount suitable to support and/or enhance atleast one of: inflammation alleviation, heart health, cardiovascularhealth, immune system regulation, liver health, hormones, brain health,cells, adrenal glands, cholesterol management, blood pressuremanagement, and insulin sensitivity.

Exemplary Formulations

Provided herein are formulations useful for treatment and stabilizationof individuals suffering from type II diabetes or at risk of developingtype II diabetes.

Provided herein is a formulation comprising: group A componentsconsisting essentially of protein selected from pea protein isolate,sacha inchi protein, hemp protein, rice protein, artichoke protein, chiaseed protein, beef protein or combinations thereof; at least one group Bcomponent that comprises dandelion extract, milk thistle extract,phospholipids, ginger, taurine, turmeric extract, vitamin C, methionineor combinations thereof; at least one group C component that comprisesmagnesium, trimethylglycine, glutathione, N-acetyl-cysteine, glutamine,alpha lipoic acid, glycine or combinations thereof; at least one group Dcomponent that comprises hesperidin, beet root, enzyme blend,sarsparilla root, bromelain, betaine, methylsulfonylmethane (MSM),choline bitartarate, primrose, inulin, watercress leaf, Panax ginsengroot extract, selenium, lecithin, or S-anenosylmethionine (SAM-e),thiamine, vitamin B5, niacin, vitamin E, riboflavin, vitamin B6, folate,vitamin B12, biotin, zinc, copper, molybdenum, carotene, calcium,vitamin D, sodium phosphate, vitamin A, calcium, phosphorus, chromium,triglyceride, quercetin, rutin, Marshmallow extract, Jerusalem artichoketuber, fiber or combinations thereof; and an excipient. In someembodiments, the enzyme blend comprises a lactase, a cellulase, aprotease, a lipase, a dismutase, a catalase, or a combination thereof.

Provided herein are formulations useful for treatment and/orstabilization of individuals suffering from type II diabetes or at riskof developing type II diabetes. In some embodiments, provided is aformulation comprising: group A components consisting essentially ofprotein selected from pea protein isolate, sacha inchi protein, hempprotein, rice protein, artichoke protein, chia seed protein, beefprotein or combinations thereof; at least one group B component thatcomprises dandelion extract, milk thistle extract, phospholipids,ginger, taurine, turmeric extract, vitamin C, methionine or combinationsthereof; at least one group C component that comprises magnesium,trimethylglycine, glutathione, N-acetyl-cysteine, Cordyceps sinensisextract, glutamine, alpha lipoic acid, glycine or combinations thereof;and an excipient. In some embodiments, the formulation further comprisespea protein isolate and sacha inchi protein. In some embodiments, theformulation further comprises a protein derived from a source which isnot pea protein isolate. In some embodiments, the formulation furthercomprises a protein derived from a source which is not sacha inchiprotein.

Further provided is a formulation comprising: group A componentsconsisting essentially of maca, Cornus officinalis fruit extract orcombinations thereof; at least one group B component that comprisesberberine, bitter melon extract, Gymnema sylvestre leaf extract, banaba,carnitine or combinations thereof; at least one group C component thatcomprises vitamin C, Panax ginseng root extract, Aswagandha rootextract, holy basil leaf extract, Rhodiola rosea extract,Eleutherococcus senticosus extract, vitamin B5, cactus stem extract,phosphatidylserine, vitamin D or combinations thereof; and an excipient.In some embodiments, the formulation further comprises a fish oilformulation. The fish oil formulation may comprise omega-3 at a range ofabout 15% to about 100%.

Also provided is a formulation comprising: group A components consistingessentially of maca, Cornus officinalis fruit extract or combinationsthereof; at least one group B component that comprises berberine, bittermelon extract, Gymnema sylvestre leaf extract, banaba, or carnitine; atleast one group C component that comprises vitamin C, Panax ginseng rootextract, Aswagandha root extract, holy basil leaf extract, Rhodiolarosea extract, Eleutherococcus senticosus extract, vitamin B5, cactusstem extract, phosphatidylserine, vitamin D or combinations thereof; atleast one group D component that comprises Cordyceps sinesis extract,Gingko biloba leaf extract, suma root, Garcinia cambogia extract,Rehmannia glutinosa extract, Poria cocos root extract, cinnamon extract,Fenugreek, Guggul, citrimax extract, salacia oblonga extract, vitamin E,thiamin, riboflavin, niacin, vitamin B6, folate, vitamin B12, biotin,magnesium, zinc, selenium, manganese, chromium, vanadium, zinc, biotin,alpha lipoic acid, N-acetyl-cysteine, 4-aminobenzoic acid (PABA),choline bitartrate, glutamine, glutathione, protein, fiber, inositol orcombinations thereof; and an excipient.

Still further provided is a formulation comprising: group A componentsconsisting essentially of cactus stem extract; at least one group Bcomponent that comprises berberine, bitter melon extract, Gymnemasylvestre leaf extract, banaba, carnitine or combinations thereof; atleast one group C component that comprises Garcinia cambogia extract,Rehmannia glutinosa extract, Poria cocos root extract, cinnamon extract,Fenugreek, Guggul, Vitamin D or combinations thereof; and an excipient.

Additionally provided is a formulation comprising: group A componentcomprising cactus stem extract; at least one of group B component thatcomprises berberine, bitter melon extract, Gymnema sylvestre leafextract, banaba, carnitine or combinations thereof; at least one group Ccomponent that comprises Garcinia cambogia extract, Rehmannia glutinosaextract, Poria cocos root extract, cinnamon extract, Fenugreek, orGuggul; at least one group D component that comprises vitamin D, vitaminE, thiamin, riboflavin, niacin, vitamin B6, folate, vitamin B12, biotin,vitamin B5, magnesium, zinc, selenium, manganese, chromium, vanadium,alpha lipoic acid, N-acetyl-cysteine, 4-aminobenzoic acid (PABA),choline bitartarate, citrimax extract, taurine, coenzyme Q10, calcium,vitamin K2, vitamin C, protein, fiber, inositol or combinations thereof;and an excipient.

In some embodiments, is a formulation comprising: group A componentsconsisting essentially of at least one protein optionally selected froma list comprising pea protein isolate and sacha inchi protein; at leastone group B component that comprises dandelion extract, milk thistleextract, phospholipids, ginger, taurine, turmeric extract, vitamin C, ormethionine; at least one group C component that comprises magnesium,trimethylglycine, glutathione, N-acetyl-cysteine, Cordyceps sinensisextract, glutamine, alpha lipoic acid, or glycine; and an excipient. Insome embodiments, the formulation further comprises pea protein isolateand sacha inchi protein. In some embodiments, the formulation furthercomprises a protein derived from a source which is not pea proteinisolate. In some embodiments, the formulation further comprises aprotein derived from a source which is not sacha inchi protein. Providedis a formulation comprising: group A components consisting essentiallyof at least one protein optionally selected from a list comprising peaprotein isolate and sacha inchi protein; at least one group B componentthat comprises about 5% to about 40% by weight of dandelion extract,about 3% to about 15% by weight of milk thistle extract, about 1% toabout 12% by weight of phospholipids, about 1% to about 10% by weight ofginger, about 0.5% to about 8% by weight of taurine, about 0.5% to about8% by weight of turmeric extract, about 1% to about 8% by weight ofvitamin C, or about 1% to about 11% by weight of methionine; at leastone group C component that comprises about 10% to about 55% by weight ofmagnesium, about 1% to about 40% by weight of trimethylglycine, about0.5% to about 35% by weight of glutathione, about 0.5% to about 30% byweight of N-acetyl-cysteine, about 0.5% to about 6% by weight ofCordyceps sinensis extract, about 0.5% to about 6% by weight ofglutamine, about 0.5% to about 6% by weight of alpha lipoic acid, orabout 0.5% to about 6% by weight of glycine; and an excipient. In someembodiments, a formulation described herein is administered to thesubject between about 2 and about 60 days. In some embodiments, theformulation is administered for about 10, 15, 20, 30, 40, 45, 50, or 60days. In certain further embodiments, the formulation is administeredfor about 30 days. In some additional embodiments, a formulationdescribed herein may be administered at fixed intervals duringadministration of a second formulation described herein. The fixedinterval may be between about two and about four months. In someembodiments, the fixed interval is about three months.

Provided is a formulation comprising: group A components consistingessentially of maca, Cornus officinalis fruit extract, and optionallybroad bean; at least one group B component that comprises berberine,bitter melon extract, Gymnema sylvestre leaf extract, banaba, orcarnitine; at least one group C component that comprises vitamin C,Panax ginseng root extract, Aswagandha root extract, holy basil leafextract, Rhodiola rosea extract, Eleutherococcus senticosus extract,vitamin B5, cactus stem extract, phosphatidylserine, or vitamin D; andan excipient. In some embodiments, the formulation further comprises afish oil formulation. The fish oil formulation may comprise omega-3 at arange of about 15% to about 100%. The fish oil formulation may alsocomprise eicosapentaenoic acid (EPA) at a range of about 5% to about100%. In some embodiments, the fish oil formulation comprisesdocosahexaenoic acid (DHA) at a range of about 10% to about 100%. Incertain embodiments, a formulation described herein is provided to asubject for a period of time which is from about one month to aboutsixty months. In some embodiments, the period of time may be from aboutsix months to about thirty six months. In some cases, this period oftime is from about twelve months to about twenty four months. In certaincases, the period of time is the time required for the subject toachieve a predetermined change in blood sugar level. In an embodiment,the period of time is the time required for the subject to achieve apredetermined reduction in hemoglobin A1C level.

Provided is a formulation comprising: group A components consistingessentially of maca, Cornus officinalis fruit extract, and optionallybroad bean; at least one group B component that comprises about 6% toabout 18% by weight of berberine, about 0.2% to about 18% by weight ofbitter melon extract, about 8% to about 18% by weight of Gymnemasylvestre leaf extract, about 0.2% to about 18% by weight of banaba, orabout 1% to about 5% by weight of carnitine; at least one group Ccomponent that comprises about 2% to about 9% by weight of vitamin C,about 5% to about 21% by weight of Panax ginseng root extract, about 4%to about 16% by weight of Aswagandha root extract, about 3% to about 13%by weight of holy basil leaf extract, about 2% to about 10% by weight ofRhodiola rosea extract, about 1% to about 7% by weight ofEleutherococcus senticosus extract, about 1% to about 7% by weightvitamin B5, about 1% to about 8% by weight of cactus stem extract, about20% to about 90% by weight of phosphatidylserine, or vitamin D; and anexcipient. In some embodiments, the formulation further comprises a fishoil formulation. The fish oil formulation may comprise omega-3 at arange of about 15% to about 100%. The fish oil formulation may alsocomprise eicosapentaenoic acid (EPA) at a range of about 5% to about100%. In some embodiments, the fish oil formulation comprisesdocosahexaenoic acid (DHA) at a range of about 10% to about 100%.

Provided is a formulation comprising: group A components consistingessentially of cactus stem extract and optionally broad bean; at leastone group B component that comprises berberine, bitter melon extract,Gymnema sylvestre leaf extract, banaba, or carnitine; at least one groupC component that comprises Garcinia cambogia extract, Rehmanniaglutinosa extract, Poria cocos root extract, cinnamon extract,Fenugreek, Guggul, or Vitamin D; and an excipient. In some embodimentsis provided a formulation comprising: group A components cactus stemextract and optionally broad bean; group B components comprising one ormore of about 6% to about 28% by weight of berberine, about 0.2% toabout 18% by weight of bitter melon extract, about 8% to about 18% byweight of Gymnema sylvestre leaf extract, about 0.2% to about 18% byweight of banaba, and about 2% to about 5% by weight of carnitine; groupC components comprising one or more of Garcinia cambogia extract,Rehmannia glutinosa extract, Poria cocos root extract, cinnamon extract,Fenugreek, and Guggul, wherein the concentration of each of the group Ccomponents is from about 0.2% to about 0.6% by weight; vitamin D; and anexcipient. In certain cases, the formulation is provided to a subjectfor a period of time which is from about 1 month to about the remaininglifetime of the subject.

In some embodiments is a formulation described herein, wherein dandelionextract is dandelion root extract. In some embodiments is a formulationdescribed herein, wherein the phospholipids comprise about 40%phosphatidylcholine. In some embodiments is a formulation describedherein, wherein the turmeric extract comprises about 95% curcumin. Insome embodiments is a formulation described herein, wherein milk thistleextract is milk thistle seed extract comprises about 80% silymarin. Insome embodiments is a formulation described herein, optionally furthercomprising a gotu kola extract, which is optionally a gotu kola leafextract. In some embodiments is a formulation described herein, whereinvitamin C comprises L-ascorbic acid, calcium ascorbate, or a combinationthereof. In some embodiments is a formulation described herein, whereinmagnesium is magnesium citrate. In some embodiments is a formulationdescribed herein, wherein glutathione comprises L-glutathione, S-acetylL-glutathione, or a combination thereof. In some embodiments is aformulation described herein, wherein N-acetyl-cysteine is N-AcetylL-cysteine. In some embodiments is a formulation described herein,wherein Cordyceps sinensis extract comprises about 7% cordycepic acid.In some embodiments is a formulation described herein, wherein glutamineis L-glutamine. In some embodiments is a formulation described herein,wherein alpha lipoic acid is alpha R-lipoic acid. In some embodiments isa formulation described herein, wherein glycine is L-glycine. In someembodiments is a formulation described herein, further comprising atleast one group D component that comprises hesperidin, beet root, enzymeblend, sarsaparilla root, bromelain, betaine, methylsulfonylmethane(MSM), choline bitartarate, luo han guo, stevia extract rebaudioside,primrose, inulin, watercress leaf, Panax ginseng root extract, selenium,or S-anenosylmethionine (SAM-e). In some embodiments is a formulationdescribed herein, wherein luo han guo comprises about 40% mogrosides. Insome embodiments is a formulation described herein, wherein the steviaextract rebaudioside is stevia extract 97% rebaudioside. In someembodiments is a formulation described herein, wherein the primrose isevening primrose oil powder. In some embodiments is a formulationdescribed herein, wherein hesperidin is hesperidin complex. In someembodiments is a formulation described herein, wherein beet root is beetroot powder. In some embodiments is a formulation described herein,wherein the enzyme blend comprises a lactase, a cellulase, a protease, alipase, a dismutase, a catalase, or a combination thereof. In someembodiments is a formulation described herein, wherein betaine isbetaine hydrochloride. In some embodiments is a formulation describedherein, wherein choline is choline bitartarate. In some embodiments is aformulation described herein, wherein the watercress leaf is watercressleaf powder. In some embodiments is a formulation described herein,wherein selenium is L-selenomethionine. In some embodiments is aformulation described herein, further comprising at least one group Ecomponent that comprises thiamine, vitamin B5, niacin, vitamin E,vitamin B6, folate, vitamin B12, biotin, zinc, copper, molybdenum,carotene, calcium, vitamin D, sodium phosphate, triglyceride, quercetin,rutin, Marshmallow extract, or Jerusalem artichoke tuber.

In some embodiments is a formulation described herein, wherein thiamineis optionally benfotiamine. In some embodiments is a formulationdescribed herein, wherein vitamin B5 comprises at least one ofpantothenic acid, pantethine, d-calcium pantothenate, or a combinationthereof. In some embodiments is a formulation described herein, whereinniacin comprises at least one of niacinamide, nicotinic acid, or acombination thereof. In some embodiments is a formulation describedherein, wherein vitamin E is d-alpha tocopherol succinate. In someembodiments is a formulation described herein, optionally furthercomprising riboflavin, wherein said riboflavin is optionallyriboflavin-5′-phosphate. In some embodiments is a formulation describedherein, wherein vitamin B6 comprises at least one ofpyridoxal-5-phosphate, pyridoxine HCl, or a combination thereof. In someembodiments is a formulation described herein, wherein folate isL-5-methyltetrahydrofolate.

In some embodiments is a formulation described herein, wherein vitaminB12 is methylcobalamin. In some embodiments is a formulation describedherein, wherein zinc is zinc glycinate. In some embodiments is aformulation described herein, wherein copper is copper gluconate. Insome embodiments is a formulation described herein, wherein molybdenumis molybdenum amino acid chelate. In some embodiments is a formulationdescribed herein, wherein carotene is beta carotene. In some embodimentsis a formulation described herein, wherein calcium is calcium ascorbate.In some embodiments is a formulation described herein, wherein vitamin Dis vitamin D3. In some embodiments is a formulation described herein,wherein sodium phosphate is disodium phosphate. In some embodiments is aformulation described herein, wherein the triglyceride is a triglyceridecomprising about 6-12 carbon fatty acid esters.

In some embodiments is a formulation described herein, wherein quercetinis quercetin dihydrate. In some embodiments is a formulation describedherein, wherein Marshmallow extract is Marshmallow root extract. In someembodiments is a formulation described herein, wherein the concentrationof pea protein isolate in the formulation is from about 5% to about 70%by weight. In some embodiments is a formulation described herein,wherein the concentration of sacha inchi protein in the formulation isfrom about 0.5% to about 10% by weight. In some embodiments is aformulation described herein, wherein the concentration of dandelionextract in the formulation is from about 5% to about 40% by weight. Insome embodiments is a formulation described herein, wherein theconcentration of milk thistle extract in the formulation is from about3% to about 15% by weight. In some embodiments is a formulationdescribed herein, wherein the concentration of phospholipids in theformulation is from about 1% to about 12% by weight. In some embodimentsis a formulation described herein, wherein the concentration of gingerin the formulation is from about 1% to about 10% by weight. In someembodiments is a formulation described herein, wherein the concentrationof taurine in the formulation is from about 0.5% to about 8% by weight.

In some embodiments is a formulation described herein, wherein theconcentration of turmeric extract in the formulation is from about 0.5%to about 8% by weight. In some embodiments is a formulation describedherein, wherein the optionally comprising gotu kola extract in aconcentration up to about 8% by weight. In some embodiments is aformulation described herein, wherein the concentration of vitamin C inthe formulation is from about 1% to about 8% by weight. In someembodiments is a formulation described herein, wherein the concentrationof methionine in the formulation is from about 1% to about 11% byweight. In some embodiments is a formulation described herein, whereinthe concentration of magnesium in the formulation is from about 10% toabout 55% by weight. In some embodiments is a formulation describedherein, wherein the concentration of trimethylglycine in the formulationis from about 1% to about 40% by weight. In some embodiments is aformulation described herein, wherein the concentration of glutathionein the formulation is from about 0.5% to about 35% by weight. In someembodiments is a formulation described herein, wherein the concentrationof N-acetyl-cysteine in the formulation is from about 0.5% to about 30%by weight. In some embodiments is a formulation described herein,wherein the concentration of Cordyceps sinensis extract in theformulation is from about 0.5% to about 6% by weight. In someembodiments is a formulation described herein, wherein the concentrationof glutamine in the formulation is from about 0.5% to about 6% byweight. In some embodiments is a formulation described herein, whereinthe concentration of alpha lipoic acid in the formulation is from about0.5% to about 6% by weight. In some embodiments is a formulationdescribed herein, wherein the concentration of glycine in theformulation is from about 0.5% to about 6% by weight.

In some embodiments is a formulation described herein, wherein theexcipient comprises gelatin, cellulose, medium-chain triglyceride (MCT)oil, silicon dioxide, stearic acid, xanthan gum, potassium sorbate,turmeric powder, primrose oil, lemon oil, or combinations thereof. Insome embodiments is a formulation described herein, wherein theformulation is in a powder form, a semi-solid form, a liquid form, anemulsion form, or a combination thereof.

In some embodiments is a formulation described herein, furthercomprising at least one component that comprises hesperidin, beet root,enzyme blend, sarsaparilla root, bromelain, betaine,methylsulfonylmethane (MSM), choline bitartarate, luo han guo, steviaextract rebaudioside, primrose, inulin, watercress leaf, Panax ginsengroot extract, selenium, or S-anenosylmethionine (SAM-e). In someembodiments is a formulation described herein, further comprising atleast one component that comprises thiamine, vitamin B5, niacin, vitaminE, riboflavin, vitamin B6, folate, vitamin B12, biotin, zinc, copper,molybdenum, carotene, calcium, vitamin D, sodium phosphate,triglyceride, quercetin, rutin, Marshmallow extract, or Jerusalemartichoke tuber. In some embodiments is a formulation described herein,wherein the phospholipids comprise about 40% phosphatidylcholine. Insome embodiments is a formulation described herein, wherein the turmericextract comprises about 95% curcumin. In some embodiments is aformulation described herein, wherein milk thistle extract is milkthistle seed extract comprising about 80% silymarin.

In some embodiments is a formulation described herein, furthercomprising gotu kola extract, wherein optionally said gotu kola extractis gotu kola leaf extract. In some embodiments is a formulationdescribed herein, wherein vitamin C comprises L-ascorbic acid, calciumascorbate, or a combination thereof. In some embodiments is aformulation described herein, wherein glutathione comprisesL-glutathione, S-acetyl L-glutathione, or a combination thereof. In someembodiments is a formulation described herein, wherein Cordycepssinensis extract comprises about 7% cordycepic acid. In some embodimentsis a formulation described herein, wherein luo han guo comprises about40% mogrosides.

In some embodiments is a formulation described herein, wherein thestevia extract rebaudioside is stevia extract 97% rebaudioside. In someembodiments is a formulation described herein, wherein the concentrationof pea protein isolate in the formulation is from about 5% to about 70%by weight. In some embodiments is a formulation described herein,wherein the concentration of sacha inchi protein in the formulation isfrom about 0.5% to about 10% by weight.

In an embodiment is a formulation described herein, wherein berberine isberberine hydrochloride. In some embodiments is a formulation describedherein, wherein carnitine is carnitine tartrate. In some embodiments isa formulation described herein, wherein carnitine is L-carnitineL-tartrate. In some embodiments is a formulation described herein,wherein the Cordyceps sinesis extract is a Cordyceps sinesis myceliumextract. In some embodiments is a formulation described herein, whereinvitamin C is L-ascorbic acid. In some embodiments is a formulationdescribed herein, wherein vitamin B5 comprises at least one ofpantothenic acid, pantethine, d-calcium pantothenate, or a combinationthereof. In some embodiments is a formulation described herein, whereinthe phosphatidylserine is a phospholipid complex supplement. In anembodiment is a formulation described herein, wherein vitamin D is apowder. In some embodiments is a formulation described herein, furthercomprising at least one component that comprises Cordyceps sinesisextract, Gingko biloba leaf extract, suma root, Garcinia cambogiaextract, Rehmannia glutinosa extract, Poria cocos root extract, cinnamonextract, Fenugreek, or Guggul.

In some embodiments is a formulation described herein, wherein Rehmanniaglutinosa extract is Rehmania glutinosa rhizome extract. In someembodiments is a formulation described herein, wherein the Rehmaniaglutinosa rhizome extract is a Rehmania glutinosa rhizome 5:1 extract.

In some embodiments is a formulation described herein, furthercomprising a fish oil formulation. In some embodiments is a formulationdescribed herein, wherein the fish oil formulation comprises omega-3 ata range of about 15% to about 100%. In some embodiments is a formulationdescribed herein, wherein the fish oil formulation compriseseicosapentaenoic acid (EPA) at a range of about 5% to about 100%. Insome embodiments the fish oil formulation comprises docosahexaenoic acid(DHA) at a range of about 10% to about 100%. In some embodiments is aformulation described herein, wherein the fish oil formulation is in apowder form. In some embodiments is a formulation described herein,wherein the fish oil formulation is in a liquid form. In someembodiments is a formulation described herein, wherein the fish oilformulation is in an emulsion form. In some embodiments is a formulationdescribed herein, wherein the fish oil formulation further comprises oneor more of citric acid, luo han guo, sodium citrate, calcium glycinateamino acid complex, magnesium glycinate, zinc glycinate chelate, zincL-monomethionine, pyridoxal-5-phosphate drum, niacin, molybdenum aminoacid chelate, taurine, lecithin, glycerine, and vitamin E.

In some embodiments is a formulation described herein, furthercomprising at least one component that comprises one or more of vitaminE, thiamin, riboflavin, niacin, vitamin B6, folate, vitamin B12, biotin,magnesium, zinc, selenium, manganese, chromium, vanadium, alpha lipoicacid, N-acetyl-cysteine, 4-aminobenzoic acid (PABA), choline bitartrate,or inositol. In some embodiments is a formulation described herein,wherein the concentration of berberine hydrochloride in the formulationis from about 6% to about 28% by weight. In some embodiments is aformulation described herein, wherein the concentration of bitter melonextract in the formulation is from about 0.2% to about 18% by weight. Insome embodiments is a formulation described herein, wherein theconcentration of Gymnema sylvestre leaf extract in the formulation isfrom about 8% to about 18% by weight. In some embodiments is aformulation described herein, wherein the concentration of banaba in theformulation is from about 0.2% to about 18% by weight. In someembodiments is a formulation described herein, wherein the concentrationof cactus stem extract in the formulation is from about 1% to about 8%by weight. In some embodiments is a formulation described herein,wherein the concentration of L-carnitine L-tartrate in the formulationis from about 1% to about 5% by weight. In some embodiments is aformulation described herein, wherein the concentration of Garciniacambogia extract in the formulation is from about 0.1% to about 1% byweight. In some embodiments is a formulation described herein, whereinthe concentration of Rehmannia glutinosa extract in the formulation isfrom about 0.1% to about 3% by weight. In some embodiments is aformulation described herein, wherein the concentration of Poria cocosroot extract in the formulation is from about 0.1% to about 1% byweight. In some embodiments is a formulation described herein, whereinthe concentration of cinnamon extract in the formulation is from about0.1% to about 1% by weight. In some embodiments is a formulationdescribed herein, wherein the concentration of Fenugreek extract in theformulation is from about 0.1% to about 1% by weight.

In some embodiments is a formulation described herein, wherein theconcentration of Guggul extract in the formulation is from about 0.1% toabout 1% by weight. In some embodiments is a formulation describedherein, optionally comprising broad bean extract which is optionally ina concentration from about 0.05% to about 0.25% by weight. In someembodiments is a formulation described herein, wherein the concentrationof Cordyceps sinesis extract in the formulation is from about 0.5% toabout 3% by weight. In some embodiments is a formulation describedherein, wherein the concentration of maca in the formulation is fromabout 0.5% to about 3% by weight. In some embodiments is a formulationdescribed herein, wherein the concentration of Gingko biloba leafextract in the formulation is from about 0.5% to about 3% by weight. Insome embodiments is a formulation described herein, wherein theconcentration of suma root extract in the formulation is from about 0.5%to about 3% by weight. In some embodiments is a formulation describedherein, wherein the concentration of Cornus officinalis fruit extract inthe formulation is from about 0.5% to about 3% by weight.

In some embodiments is a formulation described herein, wherein theconcentration of vitamin C in the formulation is from about 2% to about9% by weight. In some embodiments is a formulation described herein,wherein the concentration of Panax ginseng root extract in theformulation is from about 5% to about 21% by weight. In some embodimentsis a formulation described herein, wherein the concentration ofAswagandha root extract in the formulation is from about 4% to about 16%by weight. In some embodiments is a formulation described herein,wherein the concentration of holy basil leaf extract in the formulationis from about 3% to about 13% by weight. In some embodiments is aformulation described herein, wherein the concentration of Rhodiolarosea extract in the formulation is from about 2% to about 10% byweight. In some embodiments is a formulation described herein, whereinthe concentration of Eleutherococcus senticosus extract in theformulation is from about 1% to about 7% by weight.

In some embodiments is a formulation described herein, wherein theconcentration of vitamin B5 in the formulation is from about 1% to about7% by weight. In some embodiments is a formulation described herein,wherein the concentration of phosphatidylserine is from about 20% toabout 90% by weight. In some embodiments is a formulation describedherein, wherein the excipient comprises gelatin, cellulose, medium-chaintriglyceride (MCT) oil, silicon dioxide, stearic acid, or combinationsthereof.

In some embodiments is a formulation described herein, optionallycomprising broad bean. In some embodiments is a formulation describedherein, wherein berberine is berberine hydrochloride. In someembodiments is a formulation described herein, wherein carnitine iscarnitine tartrate. In some embodiments is a formulation describedherein, wherein carnitine is L-carnitine L-tartrate. In some embodimentsis a formulation described herein, wherein Rehmannia glutinosa extractis Rehmania glutinosa rhizome extract. In some embodiments is aformulation described herein, wherein the Rehmania glutinosa rhizomeextract is a Rehmania glutinosa rhizome 5:1 extract. In some embodimentsis a formulation described herein, wherein vitamin D is a powder. Insome embodiments is a formulation described herein, further comprisingat least one component that comprises vitamin E, thiamin, riboflavin,niacin, vitamin B6, folate, vitamin B12, biotin, vitamin B5, magnesium,zinc, selenium, manganese, chromium, vanadium, alpha lipoic acid,N-acetyl-cysteine, 4-aminobenzoic acid (PABA), choline bitartarate, orinositol. In some embodiments is a formulation described herein, whereinvitamin E is d-alpha tocopherol succinate. In some embodiments is aformulation described herein, wherein thiamin is at least one ofbenfotiamine and thiamine HCl. In some embodiments is a formulationdescribed herein, wherein riboflavin is roboflavin-5′-phosphate. In someembodiments is a formulation described herein, wherein niacin comprisesat least one of niacinamide, nicotinic acid, or a combination thereof.In some embodiments is a formulation described herein, wherein vitaminB6 is at least one of pyridoxal-5-phospate and pyridoxine HCl. In someembodiments is a formulation described herein, wherein folate isL-5-metyltetrahydrofolate.

In some embodiments is a formulation described herein, wherein vitaminB12 is cyanococbalamin. In some embodiments is a formulation describedherein, wherein vitamin B5 comprises at least one of pantothenic acid,d-calcium pantothenate, pantethine, or a combination thereof. In someembodiments is a formulation described herein, wherein magnesium ismagnesium citrate.

In some embodiments is a formulation described herein, wherein zinc iszinc glycinate. In some embodiments is a formulation described herein,wherein selenium is L-selenomethionine. In some embodiments is aformulation described herein, wherein manganese is manganese gluconate.In some embodiments is a formulation described herein, wherein chromiumis chromium niacin complex. In some embodiments is a formulationdescribed herein, wherein vanadium is vanadium sulfate. In someembodiments is a formulation described herein, wherein alpha lipoic acidis alpha R-lipoic acid. In some embodiments is a formulation describedherein, wherein N-acetyl-cysteine is N-Acetyl L-cysteine. In someembodiments is a formulation described herein, wherein the concentrationof berberine hydrochloride in the formulation is from about 6% to about28% by weight. In some embodiments is a formulation described herein,wherein the concentration of bitter melon extract in the formulation isfrom about 0.2% to about 18% by weight. In some embodiments is aformulation described herein, wherein the concentration of Gymnemasylvestre leaf extract in the formulation is from about 8% to about 18%by weight. In some embodiments is a formulation described herein,wherein the concentration of banaba in the formulation is from about0.2% to about 18% by weight. In some embodiments is a formulationdescribed herein, wherein the concentration of cactus stem extract inthe formulation is from about 3% to about 8% by weight. In someembodiments is a formulation described herein, wherein the concentrationof L-carnitine L-tartrate in the formulation is from about 2% to about5% by weight.

In some embodiments is a formulation described herein, wherein theconcentration of Garcinia cambogia extract in the formulation is fromabout 0.2% to about 0.6% by weight. In some embodiments is a formulationdescribed herein, wherein the concentration of Rehmannia glutinosaextract in the formulation is from about 0.2% to about 0.6% by weight.

In some embodiments is a formulation described herein, wherein theconcentration of Poria cocos root extract in the formulation is fromabout 0.2% to about 0.6% by weight. In some embodiments is a formulationdescribed herein, wherein the concentration of cinnamon extract in theformulation is from about 0.2% to about 0.6% by weight. In someembodiments is a formulation described herein, wherein the concentrationof Fenugreek in the formulation is from about 0.2% to about 0.6% byweight. In some embodiments is a formulation described herein, whereinthe concentration of Guggul in the formulation is from about 0.2% toabout 0.6% by weight.

In some embodiments is a formulation described herein, optionallyfurther comprising broad bean powder in a concentration from about 0.2%to about 0.6% by weight. In some embodiments is a formulation describedherein, wherein the excipient comprises gelatin, cellulose, medium-chaintriglyceride (MCT) oil, silicon dioxide, stearic acid, xanthan gum,potassium sorbate, turmeric powder, primrose oil, lemon oil, orcombinations thereof.

In some embodiments, formulations that comprise ingredients atadditional concentrations are also contemplated. In some instances, theconcentration of dandelion extract is from about 5% to about 40%, about6% to about 36%, about 8% to about 35%, about 9% to about 34%, or about10% to about 30% by weight.

In some instances, the concentration of milk thistle extract is fromabout 1% to about 20%, about 3% to about 15%, about 5% to about 12%, orabout 8% to about 10% by weight.

In some instances, the concentration of phospholipids is from about 1%to about 15%, about 1% to about 12%, about 2% to about 10%, or about 5%to about 8% by weight. In some cases, the concentration of ginger isfrom about 0.5% to about 15%, about 1% to about 10%, about 2% to about8%, or about 3% to about 6% by weight. In some instances, theconcentration of taurine is from about 0.5% to about 10%, about 1% toabout 8%, about 2% to about 7%, or about 3% to about 6% by weight. Insome instances, the concentration of curcumin is from about 0.5% toabout 10%, about 1% to about 8%, about 2% to about 7%, or about 3% toabout 6% by weight.

In some embodiments, the concentration of turmeric extract is from about0.5% to about 10%, about 1% to about 8%, about 2% to about 6%, or about3% to about 5% by weight. In some instances, the concentration ofvitamin C about 1% to about 10%, about 1% to about 8%, about 2% to about7%, or about 3% to about 6% by weight. In some instances, theconcentration of vitamin B is from about 0.5% to about 10%, about 1% toabout 10%, about 1% to about 8%, about 2% to about 7%, or about 3% toabout 6% by weight. In some embodiments, the concentration of methionineis from about 0.5% to about 15%, about 1% to about 11%, % to about 10%,about 1% to about 8%, about 2% to about 7%, or about 3% to about 6% byweight.

In some cases, the concentration of magnesium is from about 5% to about60%, about 10% to about 55%, about 12% to about 50%, or about 15% toabout 40% by weight.

In some instances, the concentration of trimethylglycine is from about0.5% to about 50%, about 1% to about 40%, about 2% to about 35%, about3% to about 30%, or about 5% to about 20% by weight.

In some instances, the concentration of glutathione is from about 0.5%to about 40%, about 0.5% to about 35%, about 1% to about 30%, about 6%to about 25%, or about 8% to about 20% by weight.

In some embodiments, the concentration of N-acetyl-cysteine is fromabout 0.5% to about 40%, about 0.5% to about 35%, about 1% to about 30%,about 6% to about 25%, or about 8% to about 20% by weight.

In some instances, the concentration of Cordyceps sinensis extract isfrom about 0.5% to about 6%, about 0.8% to about 5%, about 1% to about4%, or about 1.2% to about 3% by weight.

In some cases, the concentration of glutamine is from about 0.5% toabout 6%, about 0.8% to about 5%, about 1% to about 4%, or about 1.2% toabout 3% by weight.

In some instances, the concentration of alpha lipoic acid is from about0.5% to about 6%, about 0.8% to about 5%, about 1% to about 4%, or about1.2% to about 3% by weight.

In some instances, the concentration of glycine is from about 0.5% toabout 6%, about 0.8% to about 5%, about 1% to about 4%, or about 1.2% toabout 3% by weight.

In some instances, the concentration of selenium is from about 0.1% toabout 5% by weight. In some instances, the concentration of selenium isabout 0.2%, 0.4%, 0.6%, 0.8%, 1%, 1.2%, 1.4%, 1.6%, 1.8%, 2%, 3%, 4%, or5% by weight.

In some embodiments, the concentration of SAMe is from about 0.1% toabout 5% by weight. In some instances, the concentration of selenium isabout 0.2%, 0.4%, 0.6%, 0.8%, 1%, 1.2%, 1.4%, 1.6%, 1.8%, 2%, 3%, 4%, or5% by weight.

In some instances, the concentration of pea protein isolate is fromabout 10% to about 60%, about 11% to about 57%, about 15% to about 55%,or about 20% to about 40% by weight.

In some instances, the concentration of sacha inchi protein is fromabout 0.5% to about 10%, about 1% to about 10%, about 1% to about 8%,about 2% to about 7%, or about 3% to about 6% by weight.

In some embodiments, the concentration of maca is from about 0.5% toabout 3%. In some embodiments, the concentration of maca is about 0.6%,0.7%, 0.8%, 0.9%, 1%, 1.5%, 2%, 2.5%, or 3% by weight.

In some instances, the concentration of Cornus officinalis is from about0.5% to about 3%. In some embodiments, the concentration of Cornusofficinalis is about 0.6%, 0.7%, 0.8%, 0.9%, 1%, 1.5%, 2%, 2.5%, or 3%by weight.

In some cases, the concentration of berberine is from about 3% to about40%, about 5% to about 30%, about 6% to about 28%, about 6% to about 18%by weight.

In some instances, the concentration of bitter melon extract is fromabout 0.1% to about 20%, about 0.2% to about 18%, about 0.5% to about15%, about 1% to about 12%, or about 4% to about 8% by weight.

In some instances, the concentration of Gymnema sylvestre leaf extractis from about 3% to about 30%, about 5% to about 20%, about 6% to about18%, about 8% to about 18%, or about 10% to about 15% by weight.

In some instances, the concentration of banaba is from about 0.1% toabout 20%, about 0.2% to about 18%, about 0.5% to about 15%, about 1% toabout 12%, or about 4% to about 8% by weight.

In some cases, the concentration of carnitine is from about 1% to about5% or about 2% to about 5% by weight. In some instances, theconcentration of carnitine is about 2%, 3%, or 4%.

In some instances, the concentration of Panax ginseng root extract isfrom about 3% to about 30%, about 5% to about 21%, about 6% to about18%, or about 8% to about 15% by weight.

In some instances, the concentration of Aswagandha root extract is fromabout 1% to about 30%, about 2% to about 20%, about 4% to about 16%, orabout 6% to about 12% by weight.

In some instances, the concentration of holy basil leaf extract is fromabout 1% to about 15%, about 3% to about 13%, or about 4% to about 10%by weight.

In some instances, the concentration of Rhodiola rosea extract is fromabout 1% to about 15%, about 2% to about 10%, or about 3% to about 8% byweight.

In some cases, the concentration of Eleutherococcus senticosus extractis from about 1% to about 10%, or about 1% to about 7% by weight.

In some instances, the concentration of cactus stem extract is fromabout 1% to about 15%, or about 1% to about 8% by weight.

In some embodiments, the concentration of phosphatidylserine is fromabout 20% to about 90%, about 30% to about 80%, or about 40% to about60% by weight.

In some instances, the concentration of broad bean is from about 0.05%to about 0.3% or from about 0.1% to about 0.2% by weight.

In some embodiments, the concentration of Garcinia cambogia extract isfrom about 0.1% to about 1%, about 0.1% to about 0.7%, about 0.2% toabout 0.6%, or about 0.4% to about 0.6% by weight.

In some instances, the concentration of Rehmannia glutinosa extract isfrom about 0.1% to about 1%, about 0.1% to about 0.7%, about 0.2% toabout 0.6%, or about 0.4% to about 0.6% by weight.

In some embodiments, the concentration of Poria cocos root extract isfrom about 0.1% to about 1%, about 0.1% to about 0.7%, about 0.2% toabout 0.6%, or about 0.4% to about 0.6% by weight.

In some instances, the concentration of cinnamon extract is from about0.1% to about 1%, about 0.1% to about 0.7%, about 0.2% to about 0.6%, orabout 0.4% to about 0.6% by weight.

In some cases, the concentration of Fenugreek is from about 0.1% toabout 1%, about 0.1% to about 0.7%, about 0.2% to about 0.6%, or about0.4% to about 0.6% by weight.

In some embodiments, the concentration of Guggul is from about 0.1% toabout 1%, about 0.1% to about 0.7%, about 0.2% to about 0.6%, or about0.4% to about 0.6% by weight.

In some embodiments, the concentration of omega-3 is from about 15% toabout 100%, about 20% to about 90%, or about 25% to about 80%. In someinstances, the concentration of omega-3 is about 30%, 35%, 40%, 45%,50%, 55%, 60%, 65%, 70%, or 75%. In some cases, the omega-3concentration is calculated based on the concentration ofeicosapentaenoic acid (EPA) and/or docosahexaenoic acid (DHA). In someinstances, the concentration of EPA is from about 15% to about 100%,about 20% to about 90%, or about 25% to about 80%. In some instances,the concentration of EPA is about 30%, 35%, 40%, 45%, 50%, 55%, 60%,65%, 70%, or 75%. In some embodiments, the concentration of DHA is fromabout 15% to about 100%, about 20% to about 90%, or about 25% to about80%. In some embodiments, the concentration of DHA is about 30%, 35%,40%, 45%, 50%, 55%, 60%, 65%, 70%, or 75%.

In some embodiments, at least one formulation disclosed herein issuitable for reducing the need for insulin administration. In someembodiments, at least one formulation disclosed herein is used forhippocampus rehabilitation. In some embodiments, at least oneformulation disclosed herein is suitable for supporting, controlling,restoring, maintaining or enhancing blood sugar metabolism. In someembodiments, at least one formulation disclosed herein is suitable forstabilizing or reducing hemoglobin A1C levels. In some embodiments, atleast one formulation disclosed herein is suitable for supporting,controlling, restoring, maintaining or enhancing liver function in asubject. In some embodiments, at least one formulation disclosed hereinis suitable for supporting, controlling, restoring, maintainingenhancing normal liver function in a subject. In some embodiments, atleast one formulation disclosed herein is suitable for supporting,controlling, restoring, maintaining or enhancing gall bladder functionin a subject. In some embodiments, at least one formulation disclosedherein is suitable for supporting, controlling, restoring, maintainingor enhancing liver detoxification in a subject. In some embodiments, atleast one formulation disclosed herein is suitable for supporting,controlling, restoring, maintaining or enhancing the immune system in asubject. In some embodiments, at least one formulation disclosed hereinis suitable for supporting, controlling, restoring, maintaining orenhancing healthy brain function in a subject. In some embodiments, atleast one formulation disclosed herein is suitable for supporting,controlling, restoring, maintaining or enhancing digestion in a subject.In some embodiments, at least one formulation disclosed herein issuitable for supporting, controlling, restoring, maintaining orenhancing platelet activity in a subject.

In some embodiments, at least one formulation disclosed herein issuitable for supporting, controlling, restoring, maintaining orenhancing blood sugar metabolism. In some embodiments, at least oneformulation disclosed herein is suitable for supporting, controlling,restoring, maintaining or enhancing blood sugar in a subject withinsufficient insulin. In some embodiments, at least one formulationdisclosed herein is suitable for supporting, controlling, restoring,maintaining or enhancing liver function. In some embodiments, at leastone formulation disclosed herein is suitable for supporting,controlling, restoring, maintaining or enhancing normal cholesterollevel. In some embodiments, at least one formulation disclosed herein issuitable for supporting, controlling, restoring, maintaining orenhancing red blood cell formation. In some embodiments, at least oneformulation disclosed herein is suitable for supporting, controlling,restoring, maintaining or enhancing a healthy salt balance within thebody fluid. In some embodiments, at least one formulation disclosedherein is suitable for supporting, controlling, restoring, maintainingor enhancing gastrointestinal health. In some embodiments, at least oneformulation disclosed herein is suitable for supporting, controlling,restoring, maintaining or enhancing gall bladder function. In someembodiments, at least one formulation disclosed herein is suitable forsupporting, controlling, restoring, maintaining or enhancing liverdetoxification. In some embodiments, at least one formulation disclosedherein is suitable for supporting, controlling, restoring, maintainingor enhancing the immune system. In some embodiments, at least oneformulation disclosed herein is suitable for supporting, controlling,restoring, maintaining or enhancing a healthy brain function. In someembodiments, at least one formulation disclosed herein is suitable forsupporting, controlling, restoring, maintaining or enhancing digestion.In some embodiments, at least one formulation disclosed herein issuitable for supporting, controlling, restoring, maintaining orenhancing platelet activity. In some embodiments, at least oneformulation disclosed herein is suitable for supporting, controlling,restoring, maintaining or enhancing healthy adrenal feedback loopfunction. In some embodiments, at least one formulation disclosed hereinis suitable for supporting, controlling, restoring, maintaining orenhancing a normal sleep pattern. In some embodiments, at least oneformulation disclosed herein formulation is suitable for supporting,controlling, restoring, maintaining or enhancing mental alertness orwakefulness. In some embodiments, at least one formulation disclosedherein formulation is suitable for supporting, controlling, restoring,maintaining or enhancing normal bone density. In some embodiments, atleast one formulation disclosed herein formulation is suitable forsupporting, controlling, restoring, maintaining or enhancing hormonalbalance. In some embodiments, at least one formulation is suitable forsupporting, controlling, restoring, maintaining or enhancing cognitivefunction. In some embodiments, at least one formulation is suitable forsupporting, controlling, restoring, maintaining or enhancing thyroidfunction. In some embodiments, at least one formulation is suitable forsupporting, controlling, restoring, maintaining or enhancing normalmenstruation. In some embodiments, at least one formulation is suitablefor supporting, controlling, restoring, maintaining or enhancing jointhealth. In some embodiments, at least one formulation is suitable forsupporting, controlling, restoring, maintaining or enhancing insulinreceptor function. In some embodiments, at least one formulation issuitable for supporting, controlling, restoring, maintaining orenhancing healthy arterial wall. In some embodiments, at least oneformulation is suitable for supporting, controlling, restoring,maintaining or enhancing a healthy heart function. In some embodiments,at least one formulation is suitable for supporting, controlling,restoring, maintaining or enhancing DNA repair function. In someembodiments, at least one formulation is suitable for supporting,controlling, restoring, maintaining or enhancing dopamine production andfunction.

In some embodiments, at least one formulation disclosed herein issuitable for supporting, controlling, restoring, maintaining orenhancing the health of those suffering from diabetes (or complicationfrom diabetes) or those who are predisposed to pre-diabetes. In someembodiments, at least one formulation disclosed herein is suitable forsupporting, controlling, restoring, maintaining or enhancing the healthof those concerned with maintaining proper blood sugar control or thosewho currently have normal blood sugar but who have a history of bloodsugar control problem.

In some embodiments, at least one formulation disclosed herein issuitable for supporting, controlling, restoring, maintaining orenhancing natural liver function, natural blood sugar metabolism,natural blood sugar levels, glycemic control, natural insulin responseto glucose load, insulin health, natural iron and sugar utilization,peripheral glucose utilization, natural cellular uptake of glucose,secretions of insulin and glucagon, natural glucose tolerance, naturalinsulin receptor site sensitivity, or the activity of glucokinase.

In some embodiments, at least one formulation disclosed herein issuitable for supporting, controlling, restoring, maintaining orenhancing organ health. In some embodiments, at least one formulationdisclosed herein is suitable for supporting, controlling, restoring,maintaining or enhancing the health of the circulatory system, eyes,ears, skin, mouth (oral), soft tissue, scalp, skeletal tissue,cartilage, connective tissue, liver, kidney, gall bladder, muscle, bone,joint, hair, nails, musculoskeletal, or mucous membranes.

In some embodiments, at least one formulation disclosed herein issuitable for supporting, controlling, restoring, maintaining orenhancing natural bone growth, natural growth and repair of tissues,gene expression, cellular repair, or health and integrity of cellulartissue.

In some embodiments, at least one formulation disclosed herein issuitable for supporting, controlling, restoring, maintaining orenhancing reproductive health. In some embodiments, at least oneformulation disclosed herein is suitable for supporting, controlling,restoring, maintaining or enhancing female reproductive health, malereproductive health, menstruation health, or male sexual functionhealth.

In some embodiments, at least one formulation disclosed herein issuitable for supporting, controlling, restoring, maintaining orenhancing hormone health. In some embodiments, at least one formulationdisclosed herein is suitable for supporting, controlling, restoring,maintaining or enhancing hormone health in a subject suffering fromPolycystic Ovarian Syndrome (PCOS). In some embodiments, at least oneformulation disclosed herein is suitable for supporting, controlling,restoring, maintaining or enhancing adrenal function or adrenalhormones.

In some embodiments, at least one formulation disclosed herein issuitable for supporting, controlling, restoring, maintaining orenhancing heart and cardiovascular health. In some embodiments, at leastone formulation disclosed herein is suitable for supporting,controlling, restoring, maintaining or enhancing healthy red bloodcells, natural white blood cell levels, natural heme production, smallblood vessel health, healthy blood pressure levels, or plateletfunction.

In some embodiments, at least one formulation disclosed herein issuitable for supporting, controlling, restoring, maintaining orenhancing healthy cholesterol levels. In some embodiments, at least oneformulation disclosed herein is suitable for supporting, controlling,restoring, maintaining or enhancing triglyceride levels, naturalbreakdown of fats, or natural biliary levels. In some embodiments, atleast one formulation disclosed herein is suitable for supporting,controlling, restoring, maintaining or enhancing digestive health. Insome embodiments, at least one formulation disclosed herein is suitablefor supporting, controlling, restoring, maintaining or enhancing colonhealth, nutrient transportation, intestinal health, natural absorptionof minerals, or natural nutrient utilization.

In some embodiments, at least one formulation disclosed herein issuitable for supporting, controlling, restoring, maintaining orenhancing a healthy nervous system. In some embodiments, at least oneformulation disclosed herein is suitable for supporting, controlling,restoring, maintaining or enhancing neuro-protection, brain function andmemory, natural nerve transmission, or GABA. In some embodiments, atleast one formulation disclosed herein is suitable for supporting,controlling, restoring, maintaining or enhancing healthy stressresponses, natural stress responses, or physical and mental well-beinghealth. In some embodiments, at least one formulation disclosed hereinis suitable for supporting, controlling, restoring, maintaining orenhancing respiratory health. In some embodiments, at least oneformulation disclosed herein is suitable for supporting, controlling,restoring, maintaining or enhancing appetite control or weight control.In some embodiments, at least one formulation disclosed herein issuitable for supporting, controlling, restoring, maintaining orenhancing, homocysteine levels, natural production of nucleic acids andcreatine phosphate, the manufacture and carbohydrate utilization, fats,and amino acids, natural protein synthesis, natural enzymatic reactions,or chemical reactions. In some embodiments, at least one formulationdisclosed herein is suitable for supporting, controlling, restoring,maintaining or enhancing detoxification or neutralization of toxin. Insome embodiments, at least one formulation disclosed herein is suitablefor supporting, controlling, restoring, maintaining or enhancingantioxidant health or natural glutathione levels. In some embodiments,at least one formulation disclosed herein is suitable for supporting,controlling, restoring, maintaining or enhancing energy levels(stamina). In some embodiments, at least one formulation disclosedherein is suitable for supporting, controlling, restoring, maintainingor enhancing natural pH levels. In some embodiments, at least oneformulation disclosed herein is suitable for supporting, controlling,restoring, maintaining or enhancing natural recovery time. In someembodiments, at least one formulation disclosed herein is suitable forsupporting, controlling, restoring, maintaining or enhancing metabolismhealth. In some embodiments, at least one formulation disclosed hereinis suitable for supporting, controlling, restoring, maintaining orenhancing natural tryptophan metabolism, natural blood sugar metabolism,or methionine metabolism. In some embodiments, at least one formulationdisclosed herein is suitable for supporting, controlling, restoring,maintaining or enhancing natural thermogenesis. In some embodiments, atleast one formulation disclosed herein is suitable for supporting,controlling, restoring, maintaining or enhancing natural cell division.In some embodiments, at least one formulation disclosed herein issuitable for supporting, controlling, restoring, maintaining orenhancing the immune system health. In some embodiments, at least oneformulation disclosed herein is suitable for supporting, controlling,restoring, maintaining or enhancing healthy uric acid levels. In someembodiments, at least one formulation is suitable for controllingstress. In some embodiments, at least one formulation is suitable forrelieving stress.

In some embodiments, one or more formulations described herein may beused as a dietary supplement and/or anticancer agent. The formulationsmay comprise either the above listed ingredients, its active compounds,or said ingredients and active compounds plus one or morepharmaceutically acceptable carriers. In addition to the ingredientsdiscussed above, methods of determining active ingredients and screeningfor activity in the formulations described herein can be carried outaccording to methods known to those of skill in the art, and accordingto methods described in the examples herein. Formulations describedherein may be mixed with pharmaceutically acceptable carriers orexcipients known to those of skill in the art, and administeredaccording to methods known to those of skill in the art including:

i.) Oral Administration in the form of juice, powders, tablets,suspension, emulsifiers, capsules, granules, troches, pills,suspensions, spirits, syrups, and limonades;ii.) Injectable Administration intravenously or otherwise;iii) Topical Administration in the form of ointments, solids,suspensions, powders, paps, suppositories, aerosols, cataplasms,liniments, lotions, enemas, and emulsifiers.

In addition, well-known excipients in the form of solid or liquid maybeused. The several examples of excipients used to administer the dosageforms are as follows:

Excipients in powders and other oral powders: lactose, crystallinecellulose, starch, dextrin, calcium phosphate, calcium carbonate,synthetic and natural aluminum dioxide, magnesium oxide, dried aluminumhydroxide, magnesium stearate, and sodium bicarbonate;

Excipients in topical powders: zinc oxide, talc, starch, kaolin, boratepowder, zinc stearate, magnesium stearate, magnesium carbonate,precipitated calcium carbonate, bismuth subgallate, and potassiumaluminum sulfate powder;

Excipients in liquids: water, glycerin, propylene glycol, sweet-tastesyrup, ethanol, fatty oil, ethylene glycol, polyethylene glycol, andsorbitol;

Excipients in ointments: hydrophobic or hydrophilic base (including oilsoluble base, water-soluble base and suspended base) prepared by mixingfat, fatty oil, lanoline, Vaseline, glycerin wax, Japan wax, paraffin,paraffin sulphate, resins, higher alcohols, plastics, glycols, water, orsurfactant.

Formulations discussed herein can be administered in any of the formsconsidered herein, or otherwise known to those of skill in the art. Insome embodiments, the formulation is administered orally in a liquidform, either as an extract, concentrated extract or other liquid form.In some embodiments, the formulation is administered orally twice a day,three times a day, or four times a day, with each dosing varying between5 oz-20 oz. depending on the person's state of health, weight, severityof disease, response of disease or conditions.

A formulation described herein may be administered as a dietarysupplement to facilitate normal physiological function and growth.

In certain instance, it is appropriate to administer the formulationdisclosed herein in combination with an additional therapeutic agent. Insome embodiments, the additional therapeutic agent comprises insulin,metformin, sulfonylureas, meglitinides, thiazolidinediones, DPP-4inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, diuretics,beta-blockers, ACE inhibitors, angiotensin II receptor blockers, calciumchannel blockers, alpha blockers, alpha-2 receptor agonist, centralagonists, peripheral adrenergic inhibitors, vasodilators or acombination thereof. In some embodiments, the additional therapeuticagent comprises CETP inhibitors, FXR agonist, LXR agonist, HMG-CoAreductase inhibitors, bile acid sequestrants, niacin and relatedcompounds, PPARalpha agonists, cholesterol absorption inhibitors, ACATinhibitors, phenolic anti-oxidant, LDL receptor inducers, plateletaggregation inhibitors, ileal bile acid transporter or a combinationthereof.

Provided in Tables A-C are a formulation described herein:

TABLE A Representative ingredients and nutritional details of oneserving of an exemplary formulation described herein. The formulationmain also contain one or more additional ingredients not listed in TableA. Supplement Facts Serving size: 1 Pouch (14.5 g) Amount Amount AmountPer % Daily Per % Daily Per % Daily Serving Value Serving Value ServingValue Calories 40   1%* Zinc 12.5 mg 84% Ginger root 40 Total fat 0.5  1%* Selenium 10 mcg 15% Bromelain Concentrate 0.5   1%* Total 4 g  7%* Copper 210 mcg 11% Methylsulfonymethane 4 g   1%* carbohydrateDietary 2 g Manganese 4 mg 200%  S-Anenosylmethionine 2 g   7%* fiberSugars 0 g Chromium 40 mcg 33% Dandelion Root Powder 0 g Protein 6 gMolybdenum 200 mcg 266%  Lecithin Powder 6 g Vitamin A 850 IU  17%Trimethylglycine 550 mg * Beet Root Powder 850 IU  17% Vitamin C 250 mg416% Evening Primrose oil 450 mg * Protease 250 mg 416% powder Vitamin D50 IU  12% Inulin 460 mg * Superoxide Dismutase 50 IU  12% Vitamin E 17IU  56% Medium Chain 260 mg * Catalase 17 IU  56% Triglycerides Oilpowder Thiamine 57.5 mg 3833%  Quercetin Dihydrate 88 mg * SarsparillaRoot 57.5 mg 3833%  Riboflavin 12 mg 705% Rutin 88 mg * DI-Methionine 12mg 705% Niacin 25 mg 125% Hesperidin complex 70 mg * L-Glutathione 25 mg125% Vitamin 14 mg 700% Milk Thistle extract 230 mg * Ginseng RootPowder 14 mg 700% B6 Folate 1250 mcg 312% L-Taurine 98 mg * L-Glycine1250 mcg 312% Vitamin 700 mcg 11667%  Choline bitartrate 100 mg * AlphaR-Lipoic Acid 700 mcg 11667%  B12 Biotin 2000 mcg 667% Betaine 110 mg *Watercress Leaf Powder 2000 mcg 667% Hydrochloride Pantothenic 22 mg220% Marshmallow 30 mg * Cellulase 22 mg 220% acid Calcium 150 mg  15%Curcumin 140 mg * Lactase 150 mg  15% Phosphorus 10 mg  1% L-Glutamine250 mg * Lipase 10 mg  1% Magnesium 190 mg  48% N-Acetyl L-Cysteine 100mg * Jerusalem Artichoke 190 mg  48% † Daily Values are based on a 2,000calorie diet * Daily Value (DV) not established.

TABLE B Representative ingredients and nutritional details of oneserving of an exemplary formulation described herein. The formulationmain also contain one or more additional ingredients not listed in TableB. Supplement Facts Serving size: 1 Pouch (15.4 g) Amount Per % DailyAmount Per % Daily Amount Per % Daily Serving Value Serving ValueServing Value Calories 35 Manganese 40 mcg 84% Asiatic Dogwood Fruit 33mg * Extract Calories from Fat 5 Chromium 280 mcg 15% Cordyceps Sinensis33 mg * Extract Total fat 0.5   1%* Vanadium 20 mcg 11% Gingko Bilobaleaf 33 mg * extract Total carbohydrate 3 g  1% R-Alpha-Lipoic 84 mg200%  Maca 33 mg * Acid Dietary fiber 2 g  8% Banaba 300 mg 33% SumaRoot 33 mg * Sugars 0 g Berberine 500 mg 266%  Aswagandha Root 200 mg *Hydrochloride Protein 6 g Bitter Melon 301 mg * Holy Basil Leaf 200 mg *Extract Extract Vitamin C 150 mg 250% Cactus Stem 125 mg * RhodiolaRosea 112 mg * Extract Extract Vitamin E 1400 IU 350% CholineBitartarate 85 mg * Eleutherococcus 100 mg * Senticosus Extract Thiamine90 IU 300% Cinnamon Extract 7 mg * Pantethine 180 mg * Riboflavin 35 mg2333%  Citrimax Extract 7 mg * Superoxide 165 mg * Dismutase Niacin 10mg 588% Fenugreek 7 mg * Milk Thistle 80% 70 mg * Silymarin Vitamin B645 mg 225% Guggul 7 mg * Ginseng Root 350 mg * Extract Folate 3.8 190%Poria Cocos Root 7 mg * Salacia Oblonga 250 mg * Extract Extract VitaminB12 160 mcg  40% Rehmannia Glutinosa 40 mg * Phospholipid 330 mg *Rhizome Complex Biotin 14 mcg 234% Gymnema Sylvestre 450 mg *Phosphatidyl Serine 165 mg * Leaf Extract Magnesium 650 mcg 217%Inositol 11 mg * S-Acetyl L- 240 mg * Glutathione zinc 50 mg  13%L-Carnitine L- 96 mg * N-Acetyl L- 305 mg * Tartrate Cysteine Selenium10 mg  67% PABA 10 mg * L-Glutamine 195 mg * † Dairy Values are based ona 2,000 calorie diet. * Daily Value (DV) not established.

TABLE C Representative ingredients and nutritional details of oneserving of an exemplary formulation described herein. The formulationmain also contain one or more additional ingredients not listed in TableC. Supplement Facts Serving size: 1 Pouch (12.5 g) Amount Per % DailyAmount Per % Daily Amount Per % Daily Serving Value Serving ValueServing Value Calories 35 Folate 160 mcg 40% Cactus Stem 60 mg * ExtractCalories from 5 Vitamin B12 12 mcg 200%  Choline 85 mg * Fat BitartarateTotal fat 0.5 g   1%* Biotin 650 mcg 217%  Cinnamon 9 mg * Extract Total3 g   1%* Calcium 50 mg  5% Citrimax 12 mg * carbohydrate ExtractDietary fiber 2 g   7%* Magnesium 25 mg  6% Fenugreek 9 mg * Sugars 0 gZinc 6 mg 40% Guggul 9 mg * Protein 6 g Selenium 40 mcg 60% Pantethine75 mg * Vitamin C 360 mg 600% Manganese 5 mg 250%  Polo Cocos Root 9mg * Extract Vitamin D 1000 IU 250% Chromium 280 mcg 235%  Rehmannia 9mg * Glutinosa Rhizome Vitamin E 90 IU 300% Molybdenum 70 mcg 93%Gymnema 300 mg * Sylvestre Leaf Extract Vitamin K2 40 mcg  50% Vanadium20 mcg * Inositol 12 mg * Thiamine 29 mg 1933%  R-Alpha-Lipoic 85 mg *L-Carnitine L- 60 mg * Acid Tartrate Riboflavin 10 mg 588% Banaba 160mg * PABA 10 mg * Niacin 25 mg 125% Berberine 340 mg * N-Acetyl L- 310mg * Hydrochloride Cysteine Vitamin B6 10 mg 500% Bitter Melon 160 mg *CoQ-10 10 mg * Extract Taurine 90 mg † Daily Values are based on a 2,000calorie diet. * Daily Value (DV) not established.

Exemplary Methods

Provided herein are methods comprising administration of at least oneformulation described herein, for the treatment of diabetes in insubject. In some embodiments, are methods for the treatment ofpre-diabetic symptoms in a subject. In certain embodiments are methodsfor the regulation of blood sugar in a subject. Certain methodsdescribed herein may comprise administration of a formulation describedherein for the regulation of insulin levels in a subject.

Provided are methods for the treatment of type II diabetes in a subjectcomprising: administering to the subject a first formulation describedherein for at least about 10 days; administering to the subject a secondformulation described herein for at least about 30 days; and optionallyadministering to the subject a third formulation described herein. Insome embodiments, a formulation described herein is administered with anadditional agent. The additional agent may comprise insulin, metformin,sulfonylureas, meglitinides, thiazolidinediones, DPP-4 inhibitors, GLP-1receptor agonists, SGLT2 inhibitors, or a combination thereof.

In some embodiments is a method of supporting glucose level in asubject's blood comprising administering to the subject one or moreformulations described herein. In some embodiments is a method ofsupporting glucose level in a subject's blood comprising administeringto the subject a formulation described herein, and optionallyadministering to the subject a second formulation described herein.

Provided are methods comprising administration of at least oneformulation described herein, wherein at least one formulation isadministered orally, intravenously, intraperitoneal, subcutaneous,topically, or a combination thereof. Optionally, at least oneformulation is administered as a pill, or as two or more pills. In someembodiments, the two or more pills are administered simultaneously,sequentially, or intermittently. In some embodiments, at least oneformulation is administered as a powder formulation. In someembodiments, at least one formulation is administered as a combinationof one or more pills and a powder formulation. The combination maybeadministered simultaneously, sequentially, or intermittently.

In some methods provided herein, at least one formulation isadministered as a liquid formulation. In some cases, the liquidformulation may be obtained by reconstituting a powder formulation in aliquid. In some cases, at least one formulation is administered as acombination of one or more pills and a liquid formulation. In certainembodiments, the combination is administered simultaneously,sequentially, or intermittently.

In some methods provided herein, at least one formulation isadministered as an emulsion formulation. In certain embodiments, atleast one formulation is administered as a combination of one or morepills and an emulsion formulation. The combination maybe administeredsimultaneously, sequentially, or intermittently.

In some methods provided herein, at least one formulation is mixed infood. In some cases, the food is a beverage, a shake, or a snack. Insome instances, the beverage is tea, coffee, or energy drink. In anembodiment, the food is consumed by the subject as part of a meal ordiet plan.

Provided herein are methods of controlling blood sugar in a subject withinsufficient insulin comprising administering to the subject aformulation described herein. In some embodiments, is a method ofcontrolling blood sugar in a subject with insufficient insulincomprising administering to the subject a formulation described herein,and optionally administering to the subject at least one secondformulation described herein.

Provided is a method of supporting liver function comprisingadministering to a subject in need thereof a formulation describedherein. In some embodiments is a method of supporting liver functioncomprising administering to the subject a formulation described herein,and optionally administering to the subject at least one secondformulation described herein.

Provided is a method of maintaining normal cholesterol level comprisingadministering to a subject in need thereof a formulation describedherein. In certain embodiments, is a method of maintaining normalcholesterol level comprising administering to the subject a formulationdescribed herein, and optionally administering to the subject at leastone second formulation described herein. In some embodiments are methodsof supporting normal cholesterol level comprising administering to asubject in need thereof a formulation described herein. In someembodiments are methods of maintaining healthy arterial wall comprisingadministering to a subject in need thereof a formulation describedherein.

Provided is a method of supporting red blood cell formation comprisingadministering to a subject in need thereof a formulation describedherein.

In some embodiments is a method of for supporting, controlling,restoring, or maintaining blood sugar levels in an individual comprisingadministering to the individual an amount of at least one formulationcomprising: group A components consisting essentially of at least oneprotein optionally selected from a list comprising pea protein isolateand sacha inchi protein; at least one group B component that comprisesdandelion extract, milk thistle extract, phospholipids, ginger, taurine,turmeric extract, vitamin C, or methionine; at least one group Ccomponent that comprises magnesium, trimethylglycine, glutathione,N-acetyl-cysteine, Cordyceps sinensis extract, glutamine, alpha lipoicacid, or glycine; and an excipient.

Provided is a method of for supporting, controlling, restoring, ormaintaining blood sugar metabolism in an individual comprisingadministering to the individual an amount of at least one formulationcomprising: group A components consisting essentially of maca, Cornusofficinalis fruit extract, and optionally broad bean; at least one groupB component that comprises berberine, bitter melon extract, Gymnemasylvestre leaf extract, banaba, or carnitine; at least one group Ccomponent that comprises vitamin C, Panax ginseng root extract,Aswagandha root extract, holy basil leaf extract, Rhodiola roseaextract, Eleutherococcus senticosus extract, vitamin B5, cactus stemextract, phosphatidylserine, or vitamin D; and an excipient.

Provided is a method of for supporting, controlling, restoring, ormaintaining blood sugar metabolism in an individual comprisingadministering to the individual an amount of at least one formulationcomprising: group A components consisting essentially of cactus stemextract and optionally broad bean; at least one group B component thatcomprises berberine, bitter melon extract, Gymnema sylvestre leafextract, banaba, or carnitine; at least one group C component thatcomprises Garcinia cambogia extract, Rehmannia glutinosa extract, Poriacocos root extract, cinnamon extract, Fenugreek, Guggul, or Vitamin D;and an excipient.

In some embodiments, is a method described herein, wherein theindividual suffers from insulin insufficiency. In certain embodiments,the individual is diabetic. In some embodiments, the individual ispre-diabetic. In certain embodiments, a formulation described herein isadministered to the individual for a period of about 10, 15, 20, 30, 40,45, 50, or 60 days. In some embodiments, a formulation described hereinmay be administered to the individual said formulation for a period ofabout one month to about sixty months.

In some embodiments, a method described herein further comprises use ofa diet plan. In certain embodiments, the diet plan further comprisesrecipes. In some embodiments, the diet plan further comprises recipesfor at least one of breakfast, lunch, snacks, and dinner.

Exemplary Kits

Provided are kits for use in the methods described herein. In someembodiments are provided kits comprising at least one formulationdescribed herein; and instructions for use thereof. In certainembodiments is a kit described herein, further comprising at least onediet plan or meal plan. In some embodiments, the kit further comprisesat least one recipe.

In some embodiments is a kit useful for supporting, controlling,restoring, or maintaining blood sugar levels in an individualcomprising: at least one formulation described herein; instructions foruse of the at least one formulation; and optionally at least one dietplan.

A diet plan described herein may further comprise recipes. In someembodiments, the diet plan further comprises recipes for at least one ofbreakfast, lunch, snacks, and dinner. In some embodiments, at least onediet plan is tailored to complement said at least one formulation. Insome embodiments, the diet plan is tailored based on the level of atleast one indicator in the individual. In certain cases, the at leastone indicator is body mass index (BMI), liver fat level or hemoglobinA1C count.

In some embodiments, a kit described herein is useful for the treatmentof diabetes. In some cases, the kit is useful for the management ofblood sugar. In certain cases, the kit further comprises at least oneadditional therapeutic agent. In a few cases, the additional agentcomprises insulin, metformin, sulfonylureas, meglitinides,thiazolidinediones, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2inhibitors, or a combination thereof.

Exemplary Diet Plans

In some embodiments provided herein are diet plans (also referred to asdiet regimen or simply regimen) for implementation in conjugation withthe methods and formulations described herein. A diet plan describedherein maybe included in a method and/or kit described herein. Incertain embodiments, a diet plan described herein is tailored for theindividual based on an understanding of the symptoms exhibited by theindividual. In some embodiments, a diet plan described herein works insynergy with a method and/or formulation described herein to achieve adesired result. In some embodiments, the desired result in a reductionor stabilization of blood glucose levels. In certain embodiments, thedesired result is a reduction or elimination of insulin administration.In certain embodiments, the desired result is a reduction in BMI. Incertain embodiments, the desired result is a reduction or elimination ofone or more symptoms of type II diabetes or an associated conditiondescribed herein.

In some embodiments, the diet plans described herein, are designed tosupport some of the integral systems of human physiology, which include,but are not limited to, blood sugar metabolism, insulin receptor sitesensitivity, anti-inflammatory support, liver function,gastro-intestinal system, immune system, brain function, adrenal glandfunctions, anti-oxidant support. In some embodiments, the plans andregimens described herein, are designed to ameliorate diabetes directly.In some embodiments, the regimens described herein, are designed toameliorate the most common underlying issues associated with yourdiabetes.

In some embodiments, the diet plans described herein comprisesadministration of the compositions and formulations described herein toan individual. In some embodiments, the compositions and formulationsdescribed herein are administered in the form of pills, tablets, liquidformulations, shakes etc. In some embodiments, the shakes are flavored.In some embodiments, the compositions described herein are in the formof powders and packaged in packets or pouches. In some embodiments, theformulation in the regimen is a powder that can be mixed with cold wateror unsweetened almond milk. In some embodiments the contents of thepackets or pouches are mixed with a potable liquid, until the powder iscompletely in solution, to prepare a shake. In some embodiments theformulation in the regimen is stirred.

In some embodiments, each packet represents one dose. In someembodiments the formulation is placed in a container with a lid that canbe shaken. In some embodiments the contents of the packets or pouchesare mixed with up-to 8 ounces of water, to prepare a shake. In someembodiments the contents of the packets or pouches are mixed with lessthan 8 ounces of water, to prepare a shake. In some embodiments thecontents of the packets or pouches are mixed with up-to 8 ounces ofunsweetened almond milk, to prepare a shake. In some embodiments thecontents of the packets or pouches are mixed with less than 8 ounces ofunsweetened almond milk, to prepare a shake. In some embodiments, theamount of water or milk may be adjusted according to desired consistencyof the prepared shake. In some embodiments, the contents of the packetsor pouches are not mixed with almond milk, for administration toindividuals who are allergic to nuts.

In some embodiments, the compositions or formulations described hereinare administered, to individuals, as shakes three times a day. In someembodiments, the formulation in the regimen is taken for 30 days. Insome embodiments, the diet regimen is followed until desired quality oflife outcomes are achieved. Exemplary desired quality of life outcomescan include, but are not limited to, weight loss, improved sleeppatterns, reduced limb pains, reduced joint pains, normalized bloodpressure etc. In some embodiments, the diet regimen is followed untilnormalized blood sugar levels are achieved.

In some embodiments, the compositions described herein are taken withbreakfast. In some embodiments, the compositions described herein aretaken with lunch. In some embodiments, the compositions described hereinare taken with dinner. In some embodiments, the compositions describedherein are taken with breakfast and dinner. In some embodiments, thecompositions described herein are taken with breakfast, lunch anddinner.

In some embodiments, the regimen is accompanied by plenty of water. Insome embodiments, the regimen is accompanied by herbal teas. In someembodiments, the regimen is accompanied by decaf green tea. In someembodiments, the regimen is accompanied by fresh fruits (includingblueberries, strawberries, blackberries, lemon, banana, apple). In someembodiments, the regimen is accompanied by vegetables (including celery,carrots, zucchini, cucumbers, avocado, beets, eggplant, asparagus,onion, garlic, spinach, lettuce, butternut squash, cauliflower,broccoli, peppers, yams and sweet potatoes), beans (pinto, black, navy,white, red kidney), and peas (including fresh, split, snap). In someembodiments, the regimen is accompanied by fish. In some embodiments,the regimen is accompanied by moderate amounts of chicken. In someembodiments, the regimen is accompanied by moderate amounts of turkey.In some embodiments, the regimen is accompanied by moderate amounts oflamb. In some embodiments, the regimen is accompanied by olive oil. Insome embodiments, the regimen is accompanied by coconut oil. In someembodiments, the regimen is accompanied by flaxseed oil (in moderation).In some embodiments, the regimen is accompanied by seeds and nuts. Insome embodiments, peanuts are excluded. In some embodiments, the regimenis accompanied by almond butter. In some embodiments, the regimen isaccompanied by cashew butter. In some embodiments, the regimen isaccompanied by unsweetened almond or coconut milk. In some embodiments,the regimen is accompanied by turkey bacon (nitrate/nitrite and glutenfree). In some embodiments, the regimen is accompanied by turkey sausagepatties (nitrate/nitrite and gluten free). In some embodiments, theregimen is accompanied by skinny crisps—Plain Jane or Onion. In someembodiments, the regimen is accompanied by Stevia, xylitol, Grade BMaple Syrup, or coconut sugar. In some embodiments, the formulation inthe regimen is accompanied by a snack. In some embodiments the snackcomprises fresh berries, fruits, nuts, almond, cashew butter on apples,celery, jicama, bananas, avocado, skinny crisps-plain jane or onion, ora combination thereof.

In some embodiments, dairy (milk, cheeses, yogurt, butter) should beavoided. In some embodiments, eggs, margarine and shortening should beavoided, while being on the regimen. In some embodiments, foods preparedwith gluten should be avoided, while being on the regimen. In someembodiments, all grains (including corn, rice, quinoa) should beavoided, while being on the regimen. In some embodiments, tomatoes,tomato sauces, corn, and white potatoes should be avoided. In someembodiments, peanuts or peanut butter should be avoided, while being onthe regimen. In some embodiments, soy or products made from soy(including soymilk, meat substitutes and tofu) should be avoided, whilebeing on the regimen. In some embodiments, beef should be avoided. Insome embodiments, pork should be avoided, while being on the regimen. Insome embodiments, cold cuts should be avoided, while being on theregimen. In some embodiments, bacon should be avoided, while being onthe regimen. In some embodiments, hotdogs should be avoided. In someembodiments, canned meat should be avoided, while being on the regimen.In some embodiments, sausage should be avoided, while being on theregimen. In some embodiments, shellfish should be avoided, while beingon the regimen. In some embodiments, honey, sugar or artificialsweeteners should be avoided, while being on the regimen. In someembodiments, alcohol should be avoided, while being on the regimen. Insome embodiments, caffeine (including coffee, decaf coffee, black tea,soda/diet soda) should be avoided, while being on the regimen. In someembodiments, fruit juices should be avoided, while being on the regimen.

In some embodiments, junk foods (e.g.—soda pops, cookies, cakes,candies, ice creams etc.) should be avoided, while being on the regimen.In some embodiments, refined foods should be avoided, while being on theregimen. In some embodiments, foods that contain dairy, corn, wheat,gluten, soy should be avoided, while being on the regimen. In someembodiments, consumption of alcohol should be significantly reduced,while being on the regimen. In some embodiments, consumption of caffeineshould be significantly reduced, while being on the regimen. In someembodiments, damaged and harmful fats (e.g.—hydrogenated oils, transfats etc.) should be avoided, while being on the regimen. In someembodiments, artificial sweeteners should be avoided, while being on theregimen.

In certain embodiments, the introduction of additional food items areallowed, while an individual is administered compositions describedherein. Additional food items can include, but are not limited to,grains (including corn, rice), quinoa, tomatoes, tomato sauces, corn,white potatoes, peanut butter, soy products, pork, cold cuts, bacon, hotdog, canned meat, sausage, honey, sugar, artificial sweeteners, caffeine(including coffee, decaf coffee, black tea, soda/diet soda), fruitjuices, and caffeine. In some embodiments, only one additional food itemis introduced to the regimen and no other additional items areintroduced for about three days to about five days. In some embodiments,one or more additional items are introduced to the regimen, after aboutthree days to about five days of introducing the only one additionalitem.

In some embodiments, the diet plan is associated with a myriad ofimproved physiological outcomes, which include, but are not limited to,increase in urine output, increase in the number of daily bowelmovements, decrease in blood sugar, blood pressure, and cholesterollevels, increased energy, weight loss, decrease in need for prescriptionmedication, decrease in insulin requirements, better sleep habits,rested feeling upon rising, overall better sense of well-being,subsiding and or complete elimination of various other negativesymptoms.

In some embodiments, the diet plan or regimen comprising administrationof the compositions described herein may be associated with decreasedblood sugar, blood pressure and cholesterol levels. In some embodiments,the reduction of blood sugar levels are indicated by, low glucometerreading, irritability, light-headedness, sweating, brain fog orconfusion, shakiness, fatigue, lethargy, nervousness, anxiety,confusion, rapid heartbeat or pulse, nausea, hunger, tingling ornumbness in the lips or tongue, lack of coordination, nightmares orcrying out during sleep, seizures, or unconsciousness. In someembodiments, the individual following the regimens described herein, byconsumption of the compositions described herein, experiencing low bloodsugar levels, is recommended to consult a medical practitioner, tomanage and normalize the blood sugar levels. In some embodiments, theblood sugar levels are managed and normalized by food intake in frequentintervals. In some embodiments, the frequent interval is between about 2hr to about 3 hr. In some embodiments, the blood sugar levels aremanaged and normalized by altering the dose of blood sugar medicine. Insome embodiments, the blood sugar medicine is Insulin. In someembodiments, the blood sugar levels are managed and normalized by eatinga health snack or a meal. In some embodiments, the blood sugar medicineis Insulin. In some embodiments, the blood sugar levels are managed andnormalized by eating food items that raise blood sugar levels rapidly.

In some embodiments, the reduction of blood pressure levels areindicated by symptoms comprising headaches, fatigue, lethargy, loweredbody temperature, chill or cold feeling, or dizziness. In someembodiments, the individual following the regimens described herein, byconsumption of the compositions described herein, is recommended tomonitor his or her blood pressure levels at regular intervals. In someembodiments, the individual following the regimens described herein, byconsumption of the compositions described herein, experiencing low bloodpressure levels, is recommended to consult a medical practitioner, tomanage and normalize the blood pressure levels. In some embodiments, thereduction of cholesterol levels are indicated by symptoms comprising,cognitive changes, depression, mood changes, behavioral changes,suicidal tendencies, or sexual dysfunction. In some embodiments, theindividual following the regimens described herein, by consumption ofthe compositions described herein, experiencing lower than optimalcholesterol levels, is recommended to consult a medical practitioner, tomanage and normalize the cholesterol levels.

In some embodiments, the regimen or diet plan is a metabolic cleansingprogram, also known as a detoxification program. In some embodiments,symptoms that are consistent with detoxification may be observed. Insome embodiments, the symptoms consistent with detoxification compriseheadaches, skin breakouts, gas, increased bowel movements, body aches,bloating, irritability, brain fog, fatigue/low energy, food cravings,constipation, diarrhea, or a combination thereof. In some embodiments,these symptoms subside in a few days. In some embodiments, the symptomslisted above may be previously existing, prior to starting the regimen.

In some embodiments, the gas or bloating, constipation, and/or diarrheamay be managed by adhering to one or more of the followingrecommendations:

Ensuring enough intake of water to stay well hydrated.

Ensuring that the dietary recommendations are being followed as close to100% as possible.

Reading ingredient labels to make sure you are not consuming anythingthat is restricted with the regimen.

Consuming high quality source of fiber in nutritional supplement form.Fiber can add bulk to the stool and can be effective in relievingdiarrhea.

Reducing the dosage of the compositions described herein by about 50% toabout 75%.

If a reduction of 75% of the original dose does not cause the symptomsto significantly reduce to a tolerable level or reduce them completelystopping consumptions of the compositions described herein for a fewdays, while continuing the other dietary recommendations.

Eliminating any new dietary items that the individual was not eatingprior to starting the regimen, and only introduced to his or her diet aspart of the regimen.

If after eliminating those foods the gas and bloating are reduces to atolerable level or are eliminated completely the individual followingthe regimen is recommended to add the eliminated foods back one at atime to identify the offending food.

If the gas and bloating were present prior to starting the regimen it islikely to subside in a few days to about a week as the systemrebalances.

If any negative symptom persists for longer than 7 days or progressesand the above steps have been taken with no improvement it isrecommended to discontinue the program all together and consult a healthcare provider.

Exemplary Indications

Provided herein are methods, formulations and kits comprising dietarysupplements for administration to a subject that may be suffering fromone or more indications described herein. Exemplary indications that canbe treated, supported, prevented or cured by a method, composition,formulation, or kit comprising dietary supplements described herein arestated or enumerated throughout this description. Certain exemplaryindications are discussed in further depth below.

For instance, disclosed herein are methods, formulations and kits foradministration to an individual diagnosed with diabetes and/orcomplications associated with diabetes.

Diabetes: Diabetes mellitus is a metabolic disorder characterized byhyperglycemia and disturbances of carbohydrate, protein and fatmetabolisms or relative lack of the hormone insulin. Diabetes mellitus,often simply referred to as diabetes, is a group of metabolic diseasesin which a person has high blood sugar, either because the body does notproduce enough insulin or because cells do not respond to the insulinthat produce enough insulin or because cells do not respond to theinsulin that is produced. This high blood sugar produces the classicalsymptoms of polyuria (frequent urination), polydipsia (increased thirst)and polyphagia (increased hunger).

Types of Diabetes: Type I diabetes is characterized by loss of theinsulin-producing beta cells of the islets of Langerhans in the pancreasleading to insulin deficiency. This type of diabetes is furtherclassified as immune-mediated or idiopathic. The majority of type Idiabetes is of the immune-mediated nature, where beta cell loss is aT-cell mediated autoimmune attack. There is no known preventive measureagainst type I diabetes, which causes approximately 10% of diabetesmellitus cases in North America and Europe. Most affected people areotherwise healthy and of a healthy weight when onset occurs. Sensitivityand responsiveness to insulin are usually normal, especially in theearly stages. Type I diabetes affects children or adults but wastraditionally termed “juvenile diabetes” because it represents amajority of the diabetes cases in children. Type II diabetes ischaracterized by insulin resistance which may be combined withrelatively reduced insulin secretion. The defective responsiveness ofbody tissues to insulin is believed to involve the insulin receptor.However, the specific defects are not known. Diabetes mellitus due to aknown defect are classified separately. Type II diabetes is the mostcommon type. In the early stage of type II diabetes, the predominantabnormality is reduced insulin sensitivity. At this stage hyperglycemiacan be reversed by a variety of measures and medications that improveinsulin sensitivity or reduce glucose production by the liver. Type IIdiabetes, is believed to develop when: the receptors on cells in thebody that normally respond to the action of insulin fail to bestimulated by it (insulin resistance). In response to this more insulinmay be produced, and this over-production exhausts theinsulin-manufacturing cells in the pancreas; insufficient insulinavailable; and the insulin that is available may be abnormal andtherefore doesn't work properly. In certain embodiments, methods,formulations and kits described herein are useful for support and/ortreatment of an individual suffering from diabetes. In certainembodiments the diabetes is type I diabetes. In some cases, theindividual is diagnosed to type II diabetes. In certain embodiments, theindividual is identified as pre-disposed to diabetes. In certaininstances, the predisposition is societal or genetic.

Complications associated with diabetes: In certain embodiments, methods,formulations and kits described herein are useful for support and/ortreatment of an individual demonstrating or diagnosed with complicationsassociated with diabetes.

Skin complications: diabetes affects every part of the body, includingthe skin. In fact, such problems are sometimes the first sign that aperson has diabetes. These include bacterial infections, fungalinfections, and itching. Other skin problems happen mostly or only topeople with diabetes. These include but are not limited to acanthosisnigricans, diabetic dermopathy, necrobiosis lipoidica diabeticorum,diabetic blisters, eruptive xanthomatosis, digital sclerosis, anddisseminated granuloma annulare. Diabetes can cause changes in the skinof the feet. At times the feet may become very dry. The skin may peeland crack. In certain cases, the nerves that control the oil andmoisture in the feet are no longer functioning. In certain embodiments,methods, formulations and kits described herein are useful for supportand/or treatment of an individual suffering from skin complicationsassociated with diabetes.

Eye complications: these include glaucoma (people with diabetes are 40%more likely to suffer from glaucoma than people without diabetes),cataracts (people with diabetes are 60% more likely to developcataract), retinopathy (including nonproliferative retinopathy, macularedema, and proliferative retinopathy). In certain embodiments, methods,formulations and kits described herein are useful for support and/ortreatment of an individual suffering from eye complications associatedwith diabetes.

Neuropathy (nerve damage): nerve damage from diabetes is called diabeticneuropathy. About half of all people with diabetes have some form ofnerve damage. It is more common in those who have had the disease for anumber of years and can lead to many kinds of problems. If the bloodglucose levels are kept on target, it may help prevent or delay nervedamage. Although it can hurt, diabetic nerve damage can also lessen theability to feel pain, heat, and cold. Loss of feeling often means thepatient may not feel a foot injury. Nerve damage can also lead tochanges in the shape of the feet and toes. In certain embodiments,methods, formulations and kits described herein are useful for supportand/or treatment of an individual suffering from neuropathy.

Foot complications: such as calluses, foot ulcers, poor circulation oramputation. Calluses occur more often and build up faster on the feet ofpeople with diabetes. Foot ulcers occur most often on the ball of thefoot or on the bottom of the big toe. Ulcers on the sides of the footare usually due to poorly fitting shoes. People with diabetes are farmore likely to have a foot or leg amputated than other people. Manypeople with diabetes have peripheral arterial disease (PAD), whichreduces blood flow to the feet. Also, many people with diabetes havenerve disease, which reduces sensation. Together, these problems make iteasy to get ulcers and infections that may lead to amputation. Incertain embodiments, methods, formulations and kits described herein areuseful for support and/or treatment of an individual suffering from orat risk of foot complications that may be associated with diabetes.

Diabetic ketoacidosis (DKA): Diabetic ketoacidosis (DKA) is a seriouscondition that can lead to diabetic coma (passing out for a long time)or even death. When the cells don't get the glucose they need forenergy, the body begins to burn fat for energy, which produces ketones.Ketones are acids that build up in the blood and appear in the urinewhen the body doesn't have enough insulin. They are a warning sign thatthe diabetes is out of control. High levels of ketones can poison thebody. In certain embodiments, methods, formulations and kits describedherein are useful for support and/or treatment of an individualsuffering from or at risk of diabetic ketoacidosis.

Kidney disease (Nephropathy): Inside kidneys are millions of tiny bloodvessels that act as filters. Their job is to remove waste products fromthe blood. Sometimes this filtering system breaks down. Diabetes candamage the kidneys and cause them to fail. Failing lose their ability tofilter out waste products, resulting in kidney disease. Diabetes candamage this system. High levels of blood sugar make the kidneys filtertoo much blood. All this extra work is hard on the filters. After manyyears, they start to leak and useful protein is lost in the urine.Having small amounts of protein in the urine is called microalbuminuria.In certain embodiments, methods, formulations and kits described hereinare useful for support and/or treatment of an individual suffering fromor at risk of kidney disease.

High blood pressure (Hypertension): nearly 1 in 3 American adults hashigh blood pressure and 2 in 3 people with diabetes report having highblood pressure or take prescription medications to lower their bloodpressure. The heart has to work harder when blood pressure is high, andthe risk for heart disease, and other problems goes up. In certainembodiments, methods, formulations and kits described herein are usefulfor support and/or treatment of an individual suffering from or at riskof high blood pressure.

Hyperosmolar Hyperglycemic Nonketotic Syndrome (HHNS): this is a seriouscondition most frequently seen in older persons. HHNS can happen topeople with either type 1 or type 2 that is not being controlledproperly, but it occurs more often in people with type 2. HHNS isusually brought on by something else, such as an illness or infection.In HHNS, blood sugar levels rise, and the body tries to get rid of theexcess sugar by passing it into the urine. Lots of urine is made atfirst, and the patient has to go to the bathroom more often. Later thepatient may not have to go to the bathroom as often, and the urinebecomes very dark. Also, the patient may be very thirsty. If HHNScontinues, the severe dehydration will lead to seizures, coma andeventually death. HHNS may take days or even weeks to develop. Incertain embodiments, methods, formulations and kits described herein areuseful for support and/or treatment of an individual suffering from orat risk of HHNS.

Gastroparesis: Disorder affecting people with both type 1 and type 2diabetes in which the stomach takes too long to empty its contents(delayed gastric emptying). The vagus nerve controls the movement offood through the digestive tract. If the vagus nerve is damaged or stopsworking, the muscles of the stomach and intestines do not work normally,and the movement of food is slowed or stopped. Just as with other typesof neuropathy, diabetes can damage the vagus nerve if blood glucoselevels remain high over a long period of time. High blood glucose causeschemical changes in nerves and damages the blood vessels that carryoxygen and nutrients to the nerves. In certain embodiments, methods,formulations and kits described herein are useful for support and/ortreatment of an individual suffering from or at risk of gastroparesis.

Heart diseases: People with diabetes have a higher-than-average risk ofhaving a heart attack or stroke. These strike people with diabetes morethan twice as often as people without diabetes. There's a big linkbetween diabetes, heart disease, and stroke. In fact, two out of threepeople with diabetes die from heart disease or stroke, also calledcardiovascular disease. Clogged blood vessels can lead to heart attack,stroke, and other problems. But there are treatments for heart disease,stroke, and blood vessel disease. In certain embodiments, methods,formulations and kits described herein are useful for support and/ortreatment of an individual suffering from or at risk of heart diseases.

Inflammation: People with type 2 diabetes don't produce enough insulinor their bodies can't use the insulin adequately. Insulin may also havean impact on tissue in the body. Its effects on tissue are influenced bymany factors, including obesity and the accumulation of fat around thebelly and on major organs in the abdomen. The fat cells can producechemicals that lead to inflammation. Scientists are only beginning tounderstand the role this form of internal inflammation may play in thedevelopment of chronic diseases like diabetes. In certain embodiments,methods, formulations and kits described herein are useful for supportand/or treatment of an individual suffering from or at risk ofinflammation.

Mental health: People with diabetes often deal with natural emotionslike stress, sadness, anger and denial before they lead to depression.In certain embodiments, methods, formulations and kits described hereinare useful for support and/or treatment of an individual suffering fromor at risk of mental health issues.

Disclosed herein are methods, formulations and kits for treating skincomplications resulting from diabetes. Disclosed herein are methods,formulations and kits for treating eye complications resulting fromdiabetes. Disclosed herein are methods, formulations and kits fortreating neuropathy resulting from diabetes. Disclosed herein aremethods, formulations and kits for treating foot complications resultingfrom diabetes. Disclosed herein are methods, formulations and kits fortreating diabetic ketoacidosis. Disclosed herein are methods,formulations and kits for treating kidney disease resulting fromdiabetes. Disclosed herein are methods, formulations and kits fortreating high blood pressure resulting from diabetes. Disclosed hereinare methods, formulations and kits for treating hyperosmolarhyperglycemic nonketotic syndrome resulting from diabetes. Disclosedherein are methods, formulations and kits for treating gastroparesisresulting from diabetes. Disclosed herein are methods, formulations andkits for treating heart disease resulting from diabetes. Disclosedherein are methods, formulations and kits for treating mental diseasesresulting from diabetes. Disclosed herein are methods, formulations andkits for treating inflammation resulting from diabetes.

High cholesterol: Abnormal cholesterol levels(hypercholesterolemia)—higher concentrations of LDL particles and lowerconcentrations of functional HDL particles—are strongly associated withcardiovascular disease because these promote atheroma development inarteries (atherosclerosis). This disease process leads to myocardialinfarction (heart attack), stroke, and peripheral vascular disease.Since higher blood LDL, especially higher LDL particle concentrationsand smaller LDL particle size, contribute to this process more than thecholesterol content of the HDL particles, LDL particles are often termed“bad cholesterol” because they have been linked to atheroma formation.On the other hand, high concentrations of functional HDL, which canremove cholesterol from cells and atheroma, offer protection and aresometimes referred to as “good cholesterol”. These balances are mostlygenetically determined, but can be changed by body build, medications,food choices, and other factors. Disclosed herein are methods,formulations and kits for treating high cholesterol and complicationsresulting from high cholesterol.

It is understood that the examples and embodiments described herein arefor illustrative purposes only and that various modifications or changesin light thereof will be suggested to persons skilled in the art and areto be included within the spirit and purview of this application andscope of the appended claims.

EXAMPLES

It is understood that the examples and embodiments described herein arefor illustrative purposes only and that various modifications or changesin light thereof will be suggested to persons skilled in the art and areto be included within the spirit and purview of this application andscope of the appended claims.

The reagents employed in the examples are commercially available or canbe prepared using commercially available instrumentation, methods, orreagents known in the art. The foregoing examples illustrate variousaspects of the invention and practice of the methods of the invention.The examples are not intended to provide an exhaustive description ofthe many different embodiments of the invention. Thus, although theforgoing invention has been described in some detail by way ofillustration and example for purposes of clarity of understanding, thoseof ordinary skill in the art will realize readily that many changes andmodifications can be made thereto without departing from the spirit orscope of the appended claims.

Example 1

Formulations and diet plans described herein were administered to 311individuals, to assess the effect of a diet comprising the formulationsdescribed herein, on biological markers and other parameters indicativeof blood glucose control. Blood levels were measured, before and afterthe administration of formulations and diet plans described herein, forthe following biological markers: glycated hemoglobin (HbAlC), totalcholesterol, triglycerides, homocysteine, C-reactive protein

(CRP), vitamin D. Other parameters that were monitored before and afterthe administration of formulations and diet plans described hereinincluded overall weight Change, requirement for oral diabetesmedications and/or insulin injections.

Out of the 311 participants, 152 (about 48%) were fully compliant withproper administration of formulations and diet plans described herein,for the entire duration of the study. The average change in thebiological markers assessed are listed in Table 1

TABLE 1 Biological Markers before and after administration BiologicalMarker Average Change in Blood Levels HbA1C 17% reduction TotalCholesterol 3.2% reduction Triglycerides 30% reduction Homocysteine 10%reduction C-reactive protein 5% increase Vitamin D 70% increase

The total number of participants, who experienced reduction in oral andparenteral (insulin) diabetic medication requirements, are listed belowin Table 2.

TABLE 2 Diabetic medication requirements before and after administrationof formulations and diet plans described herein Number of Participants/%of Parameter Compliant Participants Off Oral Medications 85/(55%) OffInsulin Injections 32/(21%) Participant became Non-Diabetic 85/(55%) atthe end of the Study

The study participants also experienced varying degrees of weight loss,and the results, grouped according to starting weights are shown below,in Table 3

TABLE 3 Weight loss after Life Support Diet Starting Weight Range FinalWeight Range Average Weight Loss 300-350 lbs. 280-320 lbs. 40 lbs.250-300 lbs. 190-260 lbs. 31 lbs. 200-250 lbs. 150-240 lbs. 24 lbs.135-200 lbs. 120-190 lbs. 16 lbs.

Collectively, the clinical study indicated that administration of aformulation described herein optionally combined with a diet plandescribed herein resulted in significant improvement in management of awide range of conditions associated with type II diabetes.

Example 2 Case Studies on Type II Diabetes Patients

The following examples describe case studies of six participants, whoexperienced remarkable improvements in diabetes and other associatedconditions, after being on the regimen, by administration of thecompositions described herein.

Study Goals: The primary goal of the study was to assess the effects ofadministering a composition described herein, using methods describedherein, on the overall glucose homeostatis in the participant. Secondarygoals included monitoring blood levels of other markers associated withimproper glucose homeostasis.

Study Design and Assessment: The participants were administered with atleast one formulation or composition described herein, and blood markerlevels were assessed before beginning administration and after being ina method or regimen comprising administration of at least oneformulation for various lengths of time.

Participant No. 1:

Clinical Background of Participant: The participant had a family historyof diabetes, elevated blood glucose levels and was under variousmedications to manage cardiovascular, endocrinal, digestive, and ocularissues.

The participant was diagnosed to have impairment in the followingmechanisms, as a result of hyperglycemia: dysglycemia, inflammation,viral infection pattern, adrenal fatigue, hippocampus dysfunction,dysregulation of hypothalamic-pituitary-adrenal axis, vitamin Ddeficiency, and intestinal dysbiosis.

Formulations described herein were administered to the individual. Thefollowing ingredients were to address dysglycemia were present in one ormore formulations administered to the individual:

Gymnema Sylvestre: The natural substance has demonstrated positiveimpacts in managing and supporting insulin resistance patterns.Specifically, it has been associated with a reduction in insulinrequirements, decrease fasting blood sugar, enhance the action ofinsulin, aid in the regeneration of pancreatic beta cells, therebycorrecting insulin resistance.

Chromium: Chromium levels are known to play a role in insulinresistance. In view of that knowledge, chromium was included in thecompositions described herein, to improve insulin resistance. Themineral was found to increases the health and sensitivity of thereceptor sites, resulting in better transport of glucose moleculesacross the cell membrane, and utilization of glucose for energyproduction, in the form of ATP.

Vanadium: This was also a critical mineral included in the compositionsdescribed herein, for managing insulin resistance.

Alpha Lipoic acid: This ingredient was also included in the compositionsdescribed herein, as it is known to improve insulin resistance byincreasing activation of glucose transporter 1 and 4 which enhanceglucose disposal by sensitizing tissues to insulin and by restoringproper intracellular redox states which then reset signalling andresponse to insulin.

Banaba Leaf Extract: The natural substance, containing triterpenoid,lager stroemin, flosin B, reginin A, and corosolic acid, which have beenshown to help regulate glucose levels, was included in the compositionsdescribed herein, to produce glucose lowering effects by enhancingperipheral glucose utilization.

Bitter Melon: The popular plant used worldwide to support patients withdiabetes.

Vitamin D: Blood levels of the prohormone Vit. D have been shown to bevery important in blood sugar metabolism, insulin receptor siteactivity, immune function, cardiovascular health, bone health, reducedrisk of some forms of cancer, musculoskeletal pain, preventative role inType 1 diabetes, and some neurodegenerative disease etc.

In addition, to manage intestinal dysbiosis, probiotic therapy wascarried out. The supplementation of probiotics has been shown tofacilitate and normalize healthy gut flora. Unhealthy gut flora(intestine dysbiosis) has been associated with intestinal permeability,malabsorption, irritable bowel disease, inflammatory bowel disease,reduced immune function, digestive distress etc.

Table 4, shows the blood levels of selected markers, measured before andafter six weeks of administering the compositions described herein, toparticipant no. 1, using the methods described herein.

Prior to After six weeks administration of of administration of BloodMarker Claimed Compositions Claimed Compositions HbA1c (glycated 7.2 6.4hemoglobin) Total Cholesterol 126 mg/dL 108 mg/dL Vitamin D 34.1 ng/mL64.7 ng/mL Absolute 3.5 2.6 Lymphocyte Count

Apart from the blood work results listed above, the participant alsoexperienced the following quality of life improvements:

A weight loss of 15 lbs. without any exercise, which indicated that theglucose metabolism was returning to homeostasis.

A reduction in the amount of prescription medication was observed withina month of being on the Life Support regimen, carried out byadministration of the composition described herein.

Increased energy levels were observed within a month of being on theLife Support regimen, carried out by administration of the compositiondescribed herein.

An improvement in eyesight, verified by an ophthalmologist, was observedwithin a month and a half of administration of the composition describedherein.

Complete elimination of peripheral neuropathy and numbness in both feet,was observed within four months of being on the Life Support regimen,carried out by administration of the composition described herein.

The reduction in weight achieved only by administration of thecompositions described herein, without any exercise was beneficial andespecially helpful for people who have medical restrictions and are notadvised exercise. The glycated hemoglobin levels were indicative of areversal from diabetic to pre-diabetic state. The reduction inlymphocyte count indicated that the immune system responded to theadministration of compositions described herein, and the viral infectionpattern was also ameliorated.

Participant No. 2:

Clinical Background of Participant: The participant suffered from TypeII diabetes and was under insulin medication, at a dosage of 20-30units, four times a day.

The participant was diagnosed to have irregularities in the followingmechanisms, as a result of hyperglycemia: dysglycemia, inflammation,liver dysfunction, fatty liver, intestinal dysbiosis.

The participant was administered formulations described herein. Thefollowing ingredients were present in one or more formulationsadministered to the participant:

Magnesium: It improved insulin resistance by optimizing insulinsecretion, activating glucose transport for insulin mediated glucoseuptake.

Biotin: It improved insulin response to glucose load, loweredpost-prandial glucose levels, and upregulated the enzyme glucokinase,which is responsible for the first step in glucose utilization by theliver.

Glutathione and Superoxide dismutase: One of the most powerfulantioxidants known to the human species, thus very important in themanagement of inflammation. The status of glutathione is considered thesingle most accurate indicator of the health of a cell. Blood sugardisorders deplete both nutrients. Also important for heart health, liverdetox, immune modulation, fatty liver and other conditions.

Carnitine, choline, inositol, taurine, L-methionine, and N-acetylcysteine promote the synthesis of phospholipids which are the buildingblocks of the lipoprotein used to transport lipids out of the liver.

Table 5, shows the blood levels of selected markers, measured before andafter six weeks of administering the compositions described herein, toparticipant no. 2, using the methods described herein.

Prior to After twelve weeks administration of of administration of BloodMarker Claimed Compositions Claimed Compositions HbA1c (glycated 8.4 6.9hemoglobin) Alanine Aminotrans- 49 IU/L 22 IU/L ferase (Liver Enzyme)Triglycerides 243 mg/dL 179 Total Cholesterol 170 146 mg/dL VLDL (VeryLow 49 mg/dL 36 mg/dL Density Lipoprotein) C-Reactive Protein 4.14 mg/dL1.94 mg/dL Vitamin D 29.7 ng/dL 60 g/dL

Apart from the blood work results listed above, the participant alsoexperienced quality of life improvements, some of which are outlined inFIG. 1A:

Reduction of Insulin from 30 units daily to 10 units daily. On certaindays, no Insulin administration was needed, based on the low bloodglucose readings.

Increased energy levels were observed within a week of being on the LifeSupport regimen, carried out by administration of the compositiondescribed herein.

Pain in joints and symptoms of restless legs were reduced within a monthof being on the Life Support regimen, carried out by administration ofthe composition described herein.

A weight loss of 25 lbs. without any exercise, which indicated that theglucose metabolism was returning to homeostasis.

Participant No. 3:

Clinical Background of Participant: The participant suffered from TypeII diabetes and was under insulin medication, about six to seven timesper day.

The participant was diagnosed to have impairment in the followingmechanisms, as a result of hyperglycemia: adrenal gland dysfunction,dysregulation of the HPA axis, evidence suggesting deterioration ofhippocampus. Saliva test performed on samples from the participantindicated adrenal stress index which is characterized by excess cortisolproduction and hippocampal dysfunction.

Formulations described herein were provided to the participant. One ormore formulations comprising the following ingredients wereadministered:

Ashwagandga root: The natural substance has adaptogenic properties,which imparts it with a capability of dealing with adrenal dysfunctionat times of high as well as low function. The glucocorticoid activitymakes it helpful in adrenal stress syndrome. It also has the ability tocounteract some of the adverse physical responses to stress such aschanges in blood sugar metabolism.

Holy basil leaf extract: Studies have shown that the holy basil preventsthe increased plasma levels of cortisol induced exposure to both chronicand acute stress, supports normal blood sugar levels, modulates HPAactivity etc.

Rhodiola: It is an adaptogenic plant that has demonstrated CentralNervous system enhancement, anti-depressant properties,anti-carcinogenic properties, and cardioprotective properties.

Pantethine and/or Pantothenic Acid: An important nutrient in stressconditions. It has demonstrated the ability to down regulate theexaggerated secretion of cortisol under times of stress as well as theability to support adrenal cortical functions when needed.

Phosphatidylserine: Has shown the ability to enhance cellular metabolismand communication, protect cells from oxidative damage, decreaseanxiety, improve mood, motivation and depression, enhance memory andcognition, and decrease cortisol. Its activity in decreasing cortisolmakes it an important factor in rehabilitating the hippocampus

Table 6, shows the blood levels of selected markers, measured before andafter six weeks of administering the compositions described herein, toparticipant no. 4, using the methods described herein.

Prior to After eight weeks administration of of administration of BloodMarker Claimed Compositions Claimed Compositions HbA1c (glycated  10 6.5hemoglobin) Alanine Aminotrans- 49 IU/L 22 IU/L ferase (Liver Enzyme)Triglycerides 199 mg/dL 169 mg/dL Total Cholesterol 195 143 mg/dL LowDensity 116 mg/dL 78 mg/dL Lipoprotein (LDL)

Apart from the blood work results listed above, the participant alsoexperienced the following quality of life improvements, some of whichare noted in FIG. 1B:

The patient did not have to continue taking any prescription drugs aftertwo months of being on the regimen.

The insulin dosage was reduced within a month, when the patient neededto take only one insulin dose at night.

There was also significant reduction in foot pain, indicative ofamelioration of diabetic neuropathy, within two months.

A total weight loss of 20 lbs, with no exercise, which indicated thatthe glucose metabolism was returning to homeostasis.

Participant No. 4:

Clinical Background of Participant: The participant suffered from TypeII diabetes and presented with very high glucose in hemoglobin levels.

Table 7, shows the blood levels of selected markers, measured before andafter six weeks of administering the compositions, to participant no. 4,described herein, using the methods described herein.

Prior to After eight weeks administration of of administration of BloodMarker Claimed Compositions Claimed Compositions HbA1c (glycated 9.1 7.6hemoglobin) Vitamin D 13.2 ng/dL 62.7 ng/dL

Apart from the blood work results listed above, the participant alsoexperienced the following quality of life improvements, some of whichare outlined in FIG. 1C:

The patient was able to eliminate all cholesterol medications within 2months and began feeling better immediately after starting the regimen.

Insulin needs were reduced within one week.

The blood sugar levels were reduce from 300 mg/dL to an average of 105mg/dL concurrently with reduction and elimination with the need forInsulin.

A total weight loss of 10 lbs, in one and half months, with no exercise,which indicated that the glucose metabolism was returning tohomeostasis.

Participant No. 5:

Table 8, shows the blood levels of selected markers, measured before andafter six weeks of administering the compositions described herein, toparticipant no. 5, using the methods described herein.

Prior to After two months administration of of administration of BloodMarker Claimed Compositions Claimed Compositions Glucose 326 mg/dL 181mg/dL HbA1c (glycated 14.8    10.8 hemoglobin) Vitamin D 13.2 ng/dL 62.7 ng/dL Triglycerides 3504 mg/dL 209 Total Cholesterol 564 mg/dL 194mg/dL LDH (lactic 289 IU/L 133 dehydrogenase) GGT (Liver Enzyme) 78 IU/L41 (amelioration of fatty liver pattern) C-Reactive Protein 6.5 mg/L   3.42 Glucose in Urine 3+ Trace Ketones in Urine 2+ Negative

Participant No. 6:

Clinical Background of Participant: The participant suffered from TypeII diabetes and had a heart surgery just before starting a regimen usingthe compositions described herein. The patient was taking over 300 unitson Insulin daily, with no improvement in blood glucose management.

Table 9, shows the blood levels of selected markers, measured before andafter six weeks of administering the compositions described herein, toparticipant no. 6, using the methods described herein.

Prior to After eight weeks administration of administration of LifeSupport of Life Support Blood Marker Compositions Compositions HbA1c(glycated  8.4 6.3  hemoglobin) Aspartate Aminotrans- 63 IU/L 22 U/Lferase (Liver Enzyme) Alanine Aminotrans- 79 U/L 23 U/L ferase (LiverEnzyme) Triglycerides 182 mg/dL 95 mg/dL Lactic dehydrogenase 289 IU/L133    (LDH) Gamma glutamyl 78 IU/L 41 (amelioration of transpeptidasefatty liver pattern) (GGT-Liver Enzyme) C-Reactive Protein 6.5 mg/L 3.42Glucose in Urine 3+ Trace Ketones in Urine 2+ Negative

Apart from the blood work results listed above, the participant alsoexperienced the following quality of life improvements:

The patient was able to completely eliminate insulin, lisinopril,cozaar, omeprazole, HCTZ, byetta, and synthroid.

The only medication that the patient had to continue taking wasmetformin, but only half of the usual dose.

A total weight loss of 150 lbs, in one and half months, with noexercise, which indicated that the glucose metabolism was returning tohomeostasis.

Summary of Case Studies: The Type 2 diabetes patients usingformulations, methods and/or kits described herein, prepared usingdietary supplements that were carefully constructed to deal with theunderlying mechanisms that cause diabetes, were shown to have desirableand positive clinical outcomes.

It is to be understood that the terminology used herein is used for thepurpose of describing specific embodiments, and is not intended to limitthe scope of the present invention. It should be noted that as usedherein, the singular forms of “a”, “an” and “the” include pluralreferences unless the context clearly dictates otherwise. In addition,unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs.

While preferable embodiments of the present invention have been shownand described herein, it will be obvious to those skilled in the artthat such embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention describedherein may be employed in practicing the invention. It is intended thatthe following claims define the scope of the invention and that methodsand structures within the scope of these claims and their equivalents becovered thereby.

1. A first formulation consisting essentially of: a) group A componentsconsisting essentially of protein selected from the group consisting ofpea protein isolate, sacha inchi protein, hemp protein, rice protein,artichoke protein, chia seed protein and beef protein, combinationsthereof; b) group B components consisting essentially of dandelionextract, milk thistle extract, ginger, taurine, turmeric extract,vitamin C, and methionine; c) group C components consisting essentiallyof magnesium, trimethylglycine, glutathione, N-acetyl-cysteine,glutamine, alpha lipoic acid, and glycine; d) group D componentconsisting essentially of hesperidin, beet root, enzyme blend,sarsparilla root, bromelain, betaine, methylsulfonylmethane (MSM),choline bitartarate, primrose, inulin, watercress leaf, Panax ginsengroot extract, selenium, lecithin, S-anenosylmethionine (SAM-e),thiamine, vitamin B5, niacin, vitamin E, riboflavin, vitamin B6, folate,vitamin B12, biotin, zinc, copper, molybdenum, carotene, calcium,vitamin D, sodium phosphate, vitamin A, phosphorus, chromium,triglyceride, quercetin, rutin, Marshmallow extract, Jerusalem artichoketuber, fiber, manganese, luo han guo, and stevia extract rebaudioside;and e) an excipient.
 2. The formulation of claim 1, wherein the enzymeblend consists essentially of a lactase, a cellulase, a protease, alipase, a dismutase, a catalase, or a combination thereof.
 3. Theformulation of claim 1, further comprising a second formulationcomprising: a) group A components consisting essentially of maca, Cornusofficinalis fruit extract or combinations thereof; b) at least one groupB component that comprises berberine, bitter melon extract, Gymnemasylvestre leaf extract, banaba, carnitine or combinations thereof; c) atleast one group C component that comprises vitamin C, Panax ginseng rootextract, Aswagandha root extract, holy basil leaf extract, Rhodiolarosea extract, Eleutherococcus senticosus extract, vitamin B5, cactusstem extract, phosphatidylserine, vitamin D or combinations thereof; d)at least one group D component that comprises Cordyceps sinesis extract,Gingko biloba leaf extract, suma root, Garcinia cambogia extract,Rehmannia glutinosa extract, Poria cocos root extract, cinnamon extract,Fenugreek, Guggul, citrimax extract, salacia oblonga extract, vitamin E,thiamin, riboflavin, niacin, vitamin B6, folate, vitamin B12, biotin,magnesium, zinc, selenium, manganese, chromium, vanadium, zinc, calcium,alpha lipoic acid, N-acetyl-cysteine, 4-aminobenzoic acid (PABA),choline bitartrate, glutamine, glutathione, protein, fiber, inositol,phospholipids, milk thistle, luo han guo, stevia extract rebaudioside,superoxide dismutase, or combinations thereof; and e) an excipient. 4.The formulation of claim 1, further comprising a third formulationcomprising: a) group A component comprising cactus stem extract; b) atleast one of group B component that comprises berberine, bitter melonextract, Gymnema sylvestre leaf extract, banaba, carnitine orcombinations thereof; c) at least one group C component that comprisesGarcinia cambogia extract, Rehmannia glutinosa extract, Poria cocos rootextract, cinnamon extract, Fenugreek, Guggul or combinations thereof; d)at least one group D component that comprises vitamin D, vitamin E,thiamin, riboflavin, niacin, vitamin B6, folate, vitamin B12, biotin,vitamin B5, magnesium, zinc, selenium, manganese, chromium, vanadium,alpha lipoic acid, N-acetyl-cysteine, 4-aminobenzoic acid (PABA),choline bitartarate, citrimax extract, taurine, coenzyme Q10, calcium,vitamin K2, vitamin C, protein, fiber, inositol, molybdenum, luo hanguo, stevia extract rebaudioside, or combinations thereof; and e) anexcipient.
 5. (canceled)
 6. (canceled)
 7. (canceled)
 8. (canceled) 9.(canceled)
 10. The formulation of claim 1, wherein the excipientcomprises gelatin, cellulose, medium-chain triglyceride (MCT) oil,silicon dioxide, stearic acid, or combinations thereof.
 11. Theformulation of claim 2, wherein the formulation is in a powder form, aliquid form, a semi-solid form, an emulsion form, or a combinationthereof.
 12. The formulation of claim 1, wherein the formulation is usedfor supporting glucose level in a subject's blood.
 13. The formulationof claim 2, wherein the formulation is used for reducing the need forinsulin administration.
 14. The formulation of claim 3, wherein theformulation is used for supporting blood sugar metabolism.
 15. A methodof supporting, controlling, restoring, or maintaining blood sugar levelsin a subject in need thereof comprising administering to the subject: a)a first formulation consisting essentially of: i. group A componentsconsisting essentially of protein selected from the group consisting ofpea protein isolate, sacha inchi protein, hemp protein, rice protein,artichoke protein, chia seed protein and beef protein, and combinationsthereof; ii. group B components consisting essentially of dandelionextract, milk thistle extract, ginger, taurine, turmeric extract,vitamin C, and methionine; iii. group C components consistingessentially of magnesium, trimethylglycine, glutathione,N-acetyl-cysteine, glutamine, alpha lipoic acid, and glycine; iv. groupD components consisting essentially of hesperidin, beet root, enzymeblend, sarsparilla root, bromelain, betaine, methylsulfonylmethane(MSM), choline bitartarate, primrose, inulin, watercress leaf, Panaxginseng root extract, selenium, lecithin, S-anenosylmethionine (SAM-e),thiamine, vitamin B5, niacin, vitamin E, riboflavin, vitamin B6, folate,vitamin B12, biotin, zinc, copper, molybdenum, carotene, calcium,vitamin D, sodium phosphate, vitamin A, phosphorus, chromium,triglyceride, quercetin, rutin, Marshmallow extract, Jerusalem artichoketuber, fiber, manganese, luo han guo, and stevia extract rebaudioside;and v. an excipient; for at least 2 days, wherein the first formulationsupports, controls, restores, or maintains blood sugar levels in thesubject, wherein the subject has diabetes or complications associatedwith diabetes.
 16. (canceled)
 17. The method of claim 15, wherein thefirst formulation is administered to the subject for about 2 to about 60days.
 18. The method of claim 22, wherein said second period of time isfrom about one month to about sixty months.
 19. The method of claim 22,wherein said second period of time is the time required for the subjectto achieve a predetermined reduction in hemoglobin A1C level.
 20. Themethod of claim 23, wherein said third period is from about 1 month toabout the remaining lifetime of the subject.
 21. (canceled)
 22. Themethod of claim 15, further comprising administering to a subject asecond formulation comprising: i. group A components consistingessentially of maca, Cornus officinalis fruit extract or combinationsthereof; ii. at least one group B component that comprises berberine,bitter melon extract, Gymnema sylvestre leaf extract, banaba, carnitineor combinations thereof; iii. at least one group C component thatcomprises vitamin C, Panax ginseng root extract, Aswagandha rootextract, holy basil leaf extract, Rhodiola rosea extract,Eleutherococcus senticosus extract, vitamin B5, cactus stem extract,phosphatidylserine, vitamin D or combinations thereof; iv. at least onegroup D component that comprises Cordyceps sinesis extract, Gingkobiloba leaf extract, suma root, Garcinia cambogia extract, Rehmanniaglutinosa extract, Poria cocos root extract, cinnamon extract,Fenugreek, Guggul, citrimax extract, salacia oblonga extract, vitamin E,thiamin, riboflavin, niacin, vitamin B6, folate, vitamin B12, biotin,magnesium, zinc, selenium, manganese, chromium, vanadium, zinc, calcium,alpha lipoic acid, N-acetyl-cysteine, 4-aminobenzoic acid (PABA),choline bitartrate, glutamine, glutathione, protein, fiber, inositol,phospholipids, milk thistle, luo han guo, stevia extract rebaudioside,superoxide dismutase, or combinations thereof; and v. an excipient; fora second period of time.
 23. The method of claim 15, further comprisingadministering to a subject a third formulation comprising: i. group Acomponent comprising cactus stem extract; ii. at least one of group Bcomponent that comprises berberine, bitter melon extract, Gymnemasylvestre leaf extract, banaba, carnitine or combinations thereof; iii.at least one group C component that comprises Garcinia cambogia extract,Rehmannia glutinosa extract, Poria cocos root extract, cinnamon extract,Fenugreek, Guggul or combinations thereof; iv. at least one group Dcomponent that comprises vitamin D, vitamin E, thiamin, riboflavin,niacin, vitamin B6, folate, vitamin B12, biotin, vitamin B5, magnesium,zinc, selenium, manganese, chromium, vanadium, alpha lipoic acid,N-acetyl-cysteine, 4-aminobenzoic acid (PABA), choline bitartarate,citrimax extract, taurine, coenzyme Q10, calcium, vitamin K2, vitamin C,protein, fiber, inositol, molybdenum, luo han guo, stevia extractrebaudioside, or combinations thereof; and v. an excipient; for a thirdperiod of time.
 24. The method of claim 15, wherein the enzyme blendconsists essentially of a lactase, a cellulase, a protease, a lipase, adismutase, a catalase, or a combination thereof.
 25. The method of claim15, wherein the excipient comprises gelatin, cellulose, medium-chaintriglyceride (MCT) oil, silicon dioxide, stearic acid, or combinationsthereof.
 26. The method of claim 15, wherein the first formulation, thesecond formulation, or the third formulation is in a powder form, aliquid form, a semi-solid form, an emulsion form, or a combinationthereof.
 27. The method of claim 15, wherein the first formulation, thesecond formulation, or the third formulation is used for supportingglucose level in a subject's blood.
 28. The method of claim 15, whereinthe first formulation, the second formulation, or the third formulationis used for reducing the need for insulin administration.
 29. The methodof claim 15, wherein the first formulation, the second formulation, orthe third formulation is used for supporting blood sugar metabolism. 30.The method of claim 15, wherein the first formulation, the secondformulation, or the third formulation is taken by a subject who isconcurrently taking one or more diabetic related medication.
 31. Themethod of claim 15, wherein the subject has type II diabetes.
 32. Themethod of claim 15, wherein the subject has type I diabetes.
 33. Themethod of claim 15, wherein the subject has skin complications, eyecomplications, foot complications, heart diseases, or inflammation. 34.The method of claim 15, wherein the subject has neuropathy, diabeticketoacidosis, kidney disease, hypertension, gastroparesis, or highcholesterol.
 35. The method of claim 15, wherein the subject haspre-diabetes.